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Protocol summary
General aims:
To determine the safety and effectiveness of Radiofrequency ablation of abdominal wall endometriosis (AWE)
Specific aims:
1. Evaluation of the safety of Radiofrequency ablation of AWE
2. Evaluation of the effectiveness of Radiofrequency ablation of AWE in reducing the volume of the lesions and pain caused by AWE lesions within 6 months after treatment.
4. Determining the rate of recurrence and complications caused by Radiofrequency ablation of AWE within 6 months after the treatment.
General aims:
To determine the safety and effectiveness of Radiofrequency ablation (RFA) of abdominal wall endometriosis (AWE)
Specific aims:
1. Evaluation of the safety of RFA of AWE
2. Evaluation of the effectiveness of RFA of AWE in reducing the volume of the lesions and pain caused by AWE lesions within 6 months after treatment.
4. Determining the rate of recurrence and complications caused by RFA of AWE within 6 months after the treatment.
General aims: To determine the safety and effectiveness of Radiofrequency ablation (RFA) of abdominal wall endometriosis (AWE) Specific aims: 1. Evaluation of the safety of Radiofrequency ablationRFA of AWE 2. Evaluation of the effectiveness of Radiofrequency ablationRFA of AWE in reducing the volume of the lesions and pain caused by AWE lesions within 6 months after treatment. 4. Determining the rate of recurrence and complications caused by Radiofrequency ablationRFA of AWE within 6 months after the treatment.
Patients over 18 years of age with an abdominal wall endometriosis (AWE) are admitted.
Exclusion criteria are the presence of more than one abdominal wall endometriosis lesion, lesion volume greater than 50 cc, history of surgery for AWE resection, heart failure, and sensitivity to Cefazolin and Bupivacaine.
Inclusion criteria: Abdominal Wall Endometriosis (AWE) diagnosis
no history of abdominal wall surgery over the past three months
patients without severe comorbidities, such as hypertension or diabetes
patients could tolerate 1-2 hours under general anesthesia
Exclusion criteria: Patients with more than 1 AWE lesion
AWE lesion volume of over 50 cc
Past surgical history of resection of AWE
Past medical history of heart failure
Allergy to cephalexin and lidocaine
Patients over 18 yearsInclusion criteria: Abdominal Wall Endometriosis (AWE) diagnosis no history of age with an abdominal wall endometriosis (AWE) are admitted.surgery over the past three months patients without severe comorbidities, such as hypertension or diabetes patients could tolerate 1-2 hours under general anesthesia Exclusion criteria are the presence of: Patients with more than one abdominal wall endometriosis1 AWE lesion, AWE lesion volume greater thanof over 50 cc, Past surgical history of surgery forresection of AWE resection,Past medical history of heart failure, Allergy to cephalexin and sensitivity to Cefazolin and Bupivacaine.lidocaine
بیماران بالای ۱۸ سال دارای یک ضایعه اندومتریوز جدار شکمی وارد میشوند.
معیارهای خروج از مطالعه شامل وجود بیش از یک ضایعه اندومتریوز جدار شکمی، حجم ضایعه بزرگتر از ۵۰ سی سی، سابقه جراحی جهت خارج سازی اندومتریوز، نارسایی قلبی و حساسیت به سفازولین و بوپیواکایین است.
شرایط ورود: بیماران با تشخیص اندومتریوز جدار شکمی
عدم وجود سابقه جراحی جدار شکمی در ۳ ماه اخیر
عدم وجود سابقه بیماری شدید مانند فشار خون و دیابت
بیمار بتواند ۱-۲ ساعت بیهوشی عمومی را تحمل کند.
شرایط خروج: وجود بیش از یک ضایعه
ضایعه اندومتریوز جدار شکمی با حجم بالای ۵۰ سی سی
سابقه جراحی جهت خارج سازی ضایعه اندومتریوز جدار شکمی
سابقه نارسایی قلبی
حساسیت به سفالکسین و لیدوکایین
شرایط ورود: بیماران بالای ۱۸ سال دارای یک ضایعهبا تشخیص اندومتریوز جدار شکمی وارد میشوندعدم وجود سابقه جراحی جدار شکمی در ۳ ماه اخیر عدم وجود سابقه بیماری شدید مانند فشار خون و دیابت بیمار بتواند ۱-۲ ساعت بیهوشی عمومی را تحمل کند. معیارهایشرایط خروج از مطالعه شامل: وجود بیش از یک ضایعه ضایعه اندومتریوز جدار شکمی، با حجم ضایعه بزرگتر ازبالای ۵۰ سی سی، سابقه جراحی جهت خارج سازی ضایعه اندومتریوز، جدار شکمی سابقه نارسایی قلبی و حساسیت به سفازولینسفالکسین و بوپیواکایین است.لیدوکایین
After hospitalization and receiving prophylactic antibiotics, the patient is subjected to radiofrequency ablation of abdominal wall endometriosis lesions under general anesthesia. Then Ethanol 98% and Bupivacaine 5% are injected into and around the lesions.
After hospitalization, the patient is subjected to radiofrequency ablation of abdominal wall endometriosis lesions under general anesthesia.
After hospitalization and receiving prophylactic antibiotics, the patient is subjected to radiofrequency ablation of abdominal wall endometriosis lesions under general anesthesia. Then Ethanol 98% and Bupivacaine 5% are injected into and around the lesions.
بعد از بستری و دریافت انتی بیوتیک پروفیلاکسی، بیمار تحت بیهوشی عمومی تحت ابلیشن به روش رادیوفرکوئنسی ضایعه قرار میگیرند. سپس اتانول ۹۸ درصد و بوپیواکائین ۵ درص به داخل و اطراف ضایعات تزریق میشود.
بعد از بستری، بیمار تحت بیهوشی عمومی تحت ابلیشن به روش رادیوفرکوئنسی ضایعه قرار میگیرند.
بعد از بستری و دریافت انتی بیوتیک پروفیلاکسی، بیمار تحت بیهوشی عمومی تحت ابلیشن به روش رادیوفرکوئنسی ضایعه قرار میگیرند. سپس اتانول ۹۸ درصد و بوپیواکائین ۵ درص به داخل و اطراف ضایعات تزریق میشود.
General information
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10
10
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2022-10-27, 1401/08/05
2022-10-27 00:00:00
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2022-12-15, 1401/09/24
2022-12-15 00:00:00
empty
2023-06-22, 1402/04/01
2023-06-22 00:00:00
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During the study, it was necessary to modify the inclusion and exclusion criteria for a group of patients with specific clinical criteria due to the differences in the patients. So the results of this study could be reliable for patients with these criteria and further studies could evaluate the efficacy of this method in other populations.
During the study, it was necessary to modify the inclusion and exclusion criteria for a group of patients with specific clinical criteria due to the differences in the patients. So the results of this study could be reliable for patients with these criteria and further studies could evaluate the efficacy of this method in other populations.
empty
در طی مطالعه لازم بود تا با توجه به تفاوت های بیماران که در نتیجه نهایی مطالعه به عنوان یک کارآزمایی بالینی فاز ۲ تاثیرگذار بود، معیار های ورود و خروج از مطالعه مجددا اصلاح گردد تا نتایج برای یک گروه از بیماران با معیار های بالینی مشخص قابل استناد باشد و در مطالعات بعدی توصیه به بررسی سایر بیماران گردد.
در طی مطالعه لازم بود تا با توجه به تفاوت های بیماران که در نتیجه نهایی مطالعه به عنوان یک کارآزمایی بالینی فاز ۲ تاثیرگذار بود، معیار های ورود و خروج از مطالعه مجددا اصلاح گردد تا نتایج برای یک گروه از بیماران با معیار های بالینی مشخص قابل استناد باشد و در مطالعات بعدی توصیه به بررسی سایر بیماران گردد.
Patients over 18 years old with an abdominal wall endometriosis lesion
Abdominal Wall Endometriosis diagnosis
no history of abdominal wall surgery over the past three months
patients without severe comorbidities, such as hypertension or diabetes
patients could tolerate 1-2 hours under general anesthesia
Patients over 18 years old with anAbdominal Wall Endometriosis diagnosis no history of abdominal wall endometriosis lesionsurgery over the past three months patients without severe comorbidities, such as hypertension or diabetes patients could tolerate 1-2 hours under general anesthesia
بیماران بالای ۱۸ سال دارای یک ضایعه اندومتریوز جدار شکمی
بیماران با تشخیص ضایعه اندومتریوز جدار شکمی
عدم وجود سابقه جراحی جدار شکمی در ۳ ماه اخیر
عدم وجود سابقه بیماری شدید مانند فشار خون و دیابت
بیمار بتواند ۱-۲ ساعت بیهوشی عمومی را تحمل کند
بیماران بالای ۱۸ سال دارای یکبا تشخیص ضایعه اندومتریوز جدار شکمی عدم وجود سابقه جراحی جدار شکمی در ۳ ماه اخیر عدم وجود سابقه بیماری شدید مانند فشار خون و دیابت بیمار بتواند ۱-۲ ساعت بیهوشی عمومی را تحمل کند
Patients with more than 1 abdominal wall endometriosis lesion
Abdominal wall endometriosis lesion volume of over 50 cc
Past surgical history of resection of abdominal wall endometriosis
Past medical history of heart failure
Allergy to Cefazolin and Bupivacaine
Patients with more than 1 abdominal wall endometriosis lesion
Abdominal wall endometriosis lesion volume of over 50 cc
Past surgical history of resection of abdominal wall endometriosis
Past medical history of heart failure
Allergy to cephalexin and lidocain
Patients with more than 1 abdominal wall endometriosis lesion Abdominal wall endometriosis lesion volume of over 50 cc Past surgical history of resection of abdominal wall endometriosis Past medical history of heart failure Allergy to Cefazolincephalexin and Bupivacainelidocain
بیماران دارای بیش از یک ضایعه اندومتریوز جدار شکمی
ضایعه اندومتریوز جدار شکمی با حجم بالای ۵۰ سی سی
سابقه جراحی جهت خارج سازی ضایعه اندومتریوز جدار شکمی
سابقه نارسایی قلبی
حساسیت به سفازولین و بوپیواکایین
بیماران دارای بیش از یک ضایعه اندومتریوز جدار شکمی
ضایعه اندومتریوز جدار شکمی با حجم بالای ۵۰ سی سی
سابقه جراحی جهت خارج سازی ضایعه اندومتریوز جدار شکمی
سابقه نارسایی قلبی
حساسیت به سفالکسین و لیدوکایین
بیماران دارای بیش از یک ضایعه اندومتریوز جدار شکمی ضایعه اندومتریوز جدار شکمی با حجم بالای ۵۰ سی سی سابقه جراحی جهت خارج سازی ضایعه اندومتریوز جدار شکمی سابقه نارسایی قلبی حساسیت به سفازولینسفالکسین و بوپیواکایینلیدوکایین
Intervention groups
#1
Intervention group: After hospitalization, 2 grams of Cefazolin is injected into the patient in order to prevent infection on the day of the procedure. The patient is put under general anesthesia with a routine protocol and cardiopulmonary monitoring is performed during the procedure. An ice pack is placed on the patient's skin at the site of the procedure to reduce injuries caused by skin burns. To burn the lesions, according to the size of the lesion, the lesions are subjected to Radiofrequency ablation for 60 seconds per cc r of the lesion. Then 2-5 cc of 98% ethanol is injected into the lesions and finally, 4-5 cc of Bupivacaine 5% is injected around the lesion.
After determining the volume of the lesions with ultrasound, the patients with receive general anesthesia and local anesthesia will be achieved with a subcutaneous injection of 1% Lidocaine. Then Radiofrequency ablation will be performed. The heating process will last 60-120 seconds, and the temperature will reach 90-95 degrees. After the ablation of each section, the transducer will move, and a nearby section will be treated similarly until the entire lesion is ablated. The patient will be closely monitored in the recovery room for six hours, and if no complications occurred, they will be sent home the same night. Prophylactic antibiotic therapy is Cephalexin 500 mg every six hours for three days.
Intervention group: After hospitalization, 2 grams of Cefazolin is injected intodetermining the patient in order to prevent infection on the dayvolume of the procedurelesions with ultrasound, the patients with receive general anesthesia and local anesthesia will be achieved with a subcutaneous injection of 1% Lidocaine. Then Radiofrequency ablation will be performed. The heating process will last 60-120 seconds, and the temperature will reach 90-95 degrees. After the ablation of each section, the transducer will move, and a nearby section will be treated similarly until the entire lesion is ablated. The patient is put under general anesthesia with a routine protocolwill be closely monitored in the recovery room for six hours, and cardiopulmonary monitoringif no complications occurred, they will be sent home the same night. Prophylactic antibiotic therapy is performed during the procedure. An ice pack is placed on the patient's skin at the site of the procedure to reduce injuries caused by skin burns. To burn the lesions, according to the size of the lesion, the lesions are subjected to Radiofrequency ablationCephalexin 500 mg every six hours for 60 seconds per cc r of the lesionthree days. Then 2-5 cc of 98% ethanol is injected into the lesions and finally, 4-5 cc of Bupivacaine 5% is injected around the lesion.
گروه مداخله: بعد از بستری در بیمارستان دو گرم سفازولین به منظور پیشگیری از عفونت در روز انجام پروسیجر به بیمار تزریق میگردد. بیمار تحت بیهوشی عمومی با پروتکل روتین قرار میگیرد و مانیتورینگ قلبی ریوی حین پروسیجر انجام میشود. بر روی پوست بیمار در محل انجام پروسیجر بسته یخ برای کاهش صدمات ناشی از سوختگی پوست قرار داده میشود. برای سوزاندن ضایعات ابتدا با توجه به حجم ضایعه، ضایعات تحت ابلیشن به روش رادیوفرکوئنسی به میزان ۶۰ ثانیه به ازای هر سانتی متر مکعب ضایعه قرار میگیرند. سپس ۲-۵ سی سی اتانول ۹۸ درصد به داخل ضایعات تزریق شده و و نهایت اطراف ضایعه ۴-۵ سی سی بوپیواکائین ۵ درصد تزریق میشود.
پس از تعیین حجم ضایعات با سونوگرافی، بیماران با بیهوشی عمومی و بی حسی موضعی با تزریق زیر جلدی لیدوکائین 1% آماده پروسیجر می شوند و سپس ابلیشن به روش رادیوفرکانسی انجام خواهد شد. فرآیند گرمایش 60-120 ثانیه طول می کشد و دما به 90-95 درجه می رسد. پس از ابلیشن هر بخش، مبدل حرکت می کند و بخش مجاور به طور مشابه تا زمانی که کل ضایعه از بین برود درمان می شود. بیمار به مدت 6 ساعت در اتاق ریکاوری تحت نظر دقیق قرار می گیرد و در صورت عدم بروز عارضه، همان شب به منزل اعزام می شود. آنتی بیوتیک درمانی پروفیلاکسی سفالکسین 500 میلی گرم هر شش ساعت به مدت سه روز خواهد بود.
گروه مداخله: بعدپس از بستری در بیمارستان دو گرم سفازولین به منظور پیشگیری از عفونت در روز انجام پروسیجر به بیمار تزریق میگردد. بیمار تحتتعیین حجم ضایعات با سونوگرافی، بیماران با بیهوشی عمومی و بی حسی موضعی با پروتکل روتین قرارتزریق زیر جلدی لیدوکائین 1% آماده پروسیجر میگیرد شوند و مانیتورینگ قلبی ریوی حین پروسیجر انجام میشود. بر روی پوست بیمار در محل انجام پروسیجر بسته یخ برای کاهش صدمات ناشی از سوختگی پوست قرار داده میشود. برای سوزاندن ضایعات ابتدا با توجه به حجم ضایعه، ضایعات تحتسپس ابلیشن به روش رادیوفرکوئنسیرادیوفرکانسی انجام خواهد شد. فرآیند گرمایش 60-120 ثانیه طول می کشد و دما به میزان ۶۰ ثانیه90-95 درجه می رسد. پس از ابلیشن هر بخش، مبدل حرکت می کند و بخش مجاور به ازای هر سانتی متر مکعبطور مشابه تا زمانی که کل ضایعه از بین برود درمان می شود. بیمار به مدت 6 ساعت در اتاق ریکاوری تحت نظر دقیق قرار میگیرند. سپس ۲-۵ سی سی اتانول ۹۸ درصد گیرد و در صورت عدم بروز عارضه، همان شب به داخل ضایعات تزریق شده و و نهایت اطراف ضایعه ۴-۵ سی سی بوپیواکائین ۵ درصد تزریقمنزل اعزام میشود. آنتی بیوتیک درمانی پروفیلاکسی سفالکسین 500 میلی گرم هر شش ساعت به مدت سه روز خواهد بود.
Protocol summary
Study aim
General aims:
To determine the safety and effectiveness of Radiofrequency ablation (RFA) of abdominal wall endometriosis (AWE)
Specific aims:
1. Evaluation of the safety of RFA of AWE
2. Evaluation of the effectiveness of RFA of AWE in reducing the volume of the lesions and pain caused by AWE lesions within 6 months after treatment.
4. Determining the rate of recurrence and complications caused by RFA of AWE within 6 months after the treatment.
Design
The study is a phase 2 clinical trial with 10 patients without a control group.
Settings and conduct
In this phase 2 clinical trial, patients with abdominal wall endometriosis who were referred to Imam Hussein Hospital from November 2022 for whom surgical treatment was not suitable or the patient personally refused to accept surgical treatment, after understanding all aspects of the treatment including the experimental nature of the treatment method, possible risks, and complications and obtaining written consent, are treated by Radiofrequency ablation for AWE lesions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Abdominal Wall Endometriosis (AWE) diagnosis
no history of abdominal wall surgery over the past three months
patients without severe comorbidities, such as hypertension or diabetes
patients could tolerate 1-2 hours under general anesthesia
Exclusion criteria: Patients with more than 1 AWE lesion
AWE lesion volume of over 50 cc
Past surgical history of resection of AWE
Past medical history of heart failure
Allergy to cephalexin and lidocaine
Intervention groups
After hospitalization, the patient is subjected to radiofrequency ablation of abdominal wall endometriosis lesions under general anesthesia.
Main outcome variables
The volume of abdominal wall endometriosis lesions before and after treatment; The score of pain in the lesion site before and after treatment
General information
Reason for update
During the study, it was necessary to modify the inclusion and exclusion criteria for a group of patients with specific clinical criteria due to the differences in the patients. So the results of this study could be reliable for patients with these criteria and further studies could evaluate the efficacy of this method in other populations.
Acronym
IRCT registration information
IRCT registration number:IRCT20220219054066N1
Registration date:2022-09-29, 1401/07/07
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:1
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
Ali Forouzannia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2613 2119
Email address
s.ali.forouzannia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-27, 1401/08/05
Expected recruitment end date
2022-11-26, 1401/09/05
Actual recruitment start date
2022-10-27, 1401/08/05
Actual recruitment end date
2022-12-15, 1401/09/24
Trial completion date
2023-06-22, 1402/04/01
Scientific title
Safety and efficacy of Radiofrequency ablation of abdominal wall endometriosis
Public title
Radiofrequency ablation of abdominal wall endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal Wall Endometriosis diagnosis
no history of abdominal wall surgery over the past three months
patients without severe comorbidities, such as hypertension or diabetes
patients could tolerate 1-2 hours under general anesthesia
Exclusion criteria:
Patients with more than 1 abdominal wall endometriosis lesion
Abdominal wall endometriosis lesion volume of over 50 cc
Past surgical history of resection of abdominal wall endometriosis
Past medical history of heart failure
Allergy to cephalexin and lidocain
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1401.006
Health conditions studied
1
Description of health condition studied
Abdominal wall endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified
Primary outcomes
1
Description
Pain score on Visual Analogue Scale
Timepoint
Pain score at the beginning of the study and 30, 90 and 180 days after treatment
Method of measurement
Visual Analogue Scale
2
Description
The volume of the lesions in abdominal Ultrasound
Timepoint
The volume of the lesions at the beginning of the study and 30, 90 and 180 days after treatment
Method of measurement
Abdominal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
After determining the volume of the lesions with ultrasound, the patients with receive general anesthesia and local anesthesia will be achieved with a subcutaneous injection of 1% Lidocaine. Then Radiofrequency ablation will be performed. The heating process will last 60-120 seconds, and the temperature will reach 90-95 degrees. After the ablation of each section, the transducer will move, and a nearby section will be treated similarly until the entire lesion is ablated. The patient will be closely monitored in the recovery room for six hours, and if no complications occurred, they will be sent home the same night. Prophylactic antibiotic therapy is Cephalexin 500 mg every six hours for three days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Seyed Ali Forouzannia
Street address
Imam Hussein Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
s.ali.forouzannia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ramin Ghahremanzadeh
Street address
Avicenna research institute, Shahid Beheshti University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2020
Email
contact@avicenna.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
0098 21 238710000
Email
mahdavi0ali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Forouzannia
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Radiology
Street address
No. 54, Saeidi Ave., Bahonar St., Niavaran,
City
Tehran
Province
Tehran
Postal code
1954964371
Phone
+98 21 2613 2119
Fax
Email
s.ali.forouzannia@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publishable data from this study include the following: age of patients, pain level before and after treatment based on visual analog scale, the volume of abdominal wall endometriosis lesions before and after treatment
When the data will become available and for how long
The access to data is available 6 months after the project results are published.
To whom data/document is available
The data obtained from this study will be available to researchers who intend to design a similar study.
Under which criteria data/document could be used
It is possible to use the data to assess the response to treatment and perform analyzes that compare the means of the variables.
From where data/document is obtainable
Researchers contact Seyed Ali Forouzannia through the email below.
s.ali.forouzannia@gmail.com
What processes are involved for a request to access data/document
The researcher must first send the proposal and approval of the ethics committee to Seyed Ali Forouzannia, and after review, the information will be provided to him within one month.