Evaluation of combined effect of Cryolipolysis with Ultrasound Cavitation and RF on body composition
To evaluate the efficacy and safety of Cryolipolysis, UC and RF for subcutaneous fat reduction
To determine whether multiple same treatments (Cryolipolysis plus both Cryo and UC and RF) result in changes in body composition
Design
Clinical trials. parallel groups.Randomized
Settings and conduct
Participants are selected from 18-65 years’ women who are referred to the center based for evaluation of Inclusion and Exclusion criterias, The services will be completely free of charge. Patients' information such as age, weight, BMI, medical history is measured by a trained technician before the start of treatment, and the body scan is used to evaluate anthropometric and body composition indicators.
Participants/Inclusion and exclusion criteria
Inclusion criteria:body mass index (BMI) greater than 27 kg/m2.age
between 18 and 65-years old.Weight change less than 5% during the last month.Sign a Consent Form.
non inclusion critria :Pregnancy.lactating in the first 6 months.Any skin disease.Taking medications or weight control supplements now or last month
Intervention groups
Participants will randomly assigned to 2 groups of 26 participants. Group one cryolipolysis and group two combination of cryolipolysis and ultrasound cavitation. Group 1 will be referred to 8 sessions with a week's interval to perform cryolipolysis. Group 2 will receive 8 steps with a distance of one second under the cryolipolysis and for stage with a two week interval for ultrasound cavitation.
Main outcome variables
waist circumference
Fat mass of trunk
BMI
Weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110726007117N8
Registration date:2019-09-17, 1398/06/26
Registration timing:retrospective
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Majid Ghayour Mobarhan
Name of organization / entity
Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1822 8573
Email address
ghayourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-02, 1397/08/11
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cryolipolysis, Ultrasound Cavitation and Radio Frequency on fat thickness as adipocity-Selective non_invasive fat reduction
Public title
Effect of non-invasive devises on fat reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI more than 25
Age between 18 and 65 years
Exclusion criteria:
Pregnancy
Lactation
Active implant device such as pacemaker, defibrillator or drug delivery
Tooth infection
History of previous surgery in the desired area
History of stroke or facial paralysis (Bell's palsy)
Botulinum toxin or injection of aesthetic drugs in the area (abdomen) during the last 6 months.
Treatment with dermal fillers, radioactive methods or laser
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type:permuted block randomization
Blocking is generally done in two ways that either the size of the groups is equal or the size of the groups is different and in this study the groups are equal. Random allocation software is used for randomization.
Sealed envelopes with a random sequence are used to hide the random allocation.
Based on the sample size of the study, some non-transparent envelopes were prepared (in order to avoid envelope content), and each of the random sequences was generated on a fixed-name card and a more transparent envelope card. For the purpose of random order retrieval, the outermost layer of the numbered packets is assigned the same order.
Finally the lid envelope lid is placed in boxes, respectively. At the beginning of registration,
Based on the order of entry of the eligible participants into the study, one of the packages named in the open order and its assigned group of participants is revealed.
A person who do a randomization is different with the person who studying the participants in terms of entry and exit criteria and registered them to study.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study data analyzer will be blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
"Ethics committee of National Institute of Medical Research Development" (NIMAD)
Street address
No 21, Besat Alley, West Fatemi ST, Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2018-06-16, 1397/03/26
Ethics committee reference number
IR.NIMAD.REC.1397.224
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
"َAnthropometric indices"
Timepoint
"before and after of the intervention"
Method of measurement
"bio impedance analyser(BIA)"
Secondary outcomes
1
Description
"Examine the satisfaction of the body composition"
Intervention Group will receive combined cryolipolysis and ultrasound cavitation. People who entered to the this group will go to 8 times under cryolipolysis and 4 times with a 2-week interval for Ultrasound cavitation.To evaluate the body composition,BIA model770 machine The construction of South Korea will be used. The Fusiomed Cryolipolysis device will be used with the BIO TEC brand in Italy, and will be usedultrasound cavitation ESM-4500ME model craft maker Mega Son, a South Korean brand.
Category
Treatment - Devices
2
Description
Control group: Cryolipolysis group. Entrants to this group will be have eight times a week for cryolipolysis.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
No.1,Parastar Ave.,Ahmad abad Blvd.Nutrition Clinic of Ghaem Hospital in Mashhad,.Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development(NIMAD)
Full name of responsible person
Mohadeseh Eskandari
Street address
No.21, Besat alley, west Fatemi st,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
nimad@research.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development(NIMAD)
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Biochemistry & Nutrition Research Center, Cardiovascular Research Centre, Avicenna (Bu-Ali) Research Institute, Mashhad University of Medical Sciences (MUMS), Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Email
ghayourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 2, Nutrition Department, school of Medicine, Mashhad University of Medical Science campus,Azady square,Mashhad,Khorasan Razavi.Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
ghayourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Khedmatgozar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 2, Vakil Abad Ave.,Azadi square.,Ferdowsi University of Mashhad.,School of Medecine.,Nutrition Departement
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Email
khedmatgozarh961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available