The main objective of this project is to evaluate the performance of the Cranfixer as claimed by the manufacturer
Design
This investigation was done in an Unblinded manner. The report was provided from the results obtained during surgery as well as post-operative follow-up.
Settings and conduct
This product has a license from the Iranian Medical Devices Directorate and the related risks are reviewed based on the essential requirements and estimated by the FMEA method, and the points are mentioned to adverse events in the instructions sheet. This study is carried out at the hospital site and also by conducting follow-up from the manufacturer's site.
Participants/Inclusion and exclusion criteria
The application of this product is in neurosurgery. The patients with craniotomy are potentially candidate to use this product. There is no limitation in terms of age and sex.
Intervention groups
The patients with craniotomy in neurosurgery
Main outcome variables
Loosening; Infection; Prominence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043740N1
Registration date:2019-06-07, 1398/03/17
Registration timing:retrospective
Last update:2019-06-07, 1398/03/17
Update count:0
Registration date
2019-06-07, 1398/03/17
Registrant information
Name
Seyed Roholah Ghodsi
Name of organization / entity
Danawell
Country
Iran (Islamic Republic of)
Phone
+98 21 8338 4167
Email address
dr.sr.ghodsi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-15, 1396/11/26
Expected recruitment end date
2018-09-17, 1397/06/26
Actual recruitment start date
2018-02-15, 1396/11/26
Actual recruitment end date
2018-12-20, 1397/09/29
Trial completion date
2019-05-02, 1398/02/12
Scientific title
Clinical Trial of Cranfixer
Public title
Cranfixer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neurosurgery that leads to the separation of the skull's flap
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
In the most cases, two Cranfixer are used to fix the flap for each patient
Actual sample size reached:
66
More than 1 sample in each individual
Actual sample size in each individual:
2
In the most cases, two Cranfixer are used to fix the flap for each patient
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
Vice-Chancellor in Research Affairs - Tehran University of Medical Sciences
Street address
Qods st., Tehran University of Medical Science (TUMS)
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.TUMS.VCR.REC.1397.657
Health conditions studied
1
Description of health condition studied
Flap Fixation instrument (Burr Hole Cover)
ICD-10 code
T84.2
ICD-10 code description
Mechanical complication of internal fixation device of other bones
Primary outcomes
1
Description
Skull Flap Loosining
Timepoint
At least 6 month after surgery
Method of measurement
Qualitative Study (Touch)
2
Description
Infection
Timepoint
2 to 4 weeks after surgery
Method of measurement
Infection detection
Secondary outcomes
1
Description
Non-Touchable from The skin
Timepoint
At least 6 month after surgery
Method of measurement
Qualitative Study (Touch)
Intervention groups
1
Description
Intervention group: Cranfixer
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahman Hospital
Full name of responsible person
Ramin Hasani
Street address
Shahrgharb,NourthIran zamin, Tehran
City
Tehran
Province
Tehran
Postal code
1465795481
Phone
+98 21 8857 5901
Email
raminhasaniiiiii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Darman Afarin Noandish Afagh
Full name of responsible person
Seyed Roholah Ghodsi
Street address
Dental Martial Incubation Center, Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1417614361
Phone
+98 21 8338 4167
Fax
+98 21 8338 4169
Email
info@danawell.com
Web page address
http://www.danawell.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Darman Afarin Noandish Afagh
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Darman Afarin Noandish Afagh
Full name of responsible person
Seyed Roholah Ghodsi
Position
CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Qods st.
City
Tehran
Province
Tehran
Postal code
1417614361
Phone
+98 21 8338 4167
Fax
+98 21 8338 4169
Email
roholahghodsi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ghodsi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8338 4167
Email
ghodsism@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Darman Afarin Noandish Afagh
Full name of responsible person
Zahra Faraji
Position
Organization representative
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Qods st.
City
Tehran
Province
Tehran
Postal code
1417614361
Phone
+98 21 8338 4167
Fax
+98 21 8338 4169
Email
zahrafaraji63@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Table of postoperative Information of patients. Data will be shared after unidentifiable people.
When the data will become available and for how long
Access to data is possible at the time of publishing results
To whom data/document is available
Individuals approved by the this team and the manufacturer
Under which criteria data/document could be used
If a person wants to access patient files, such as CT-scan for further study, it is possible with the manufacturer's permission. furthermore, the provided report from this study should be published with permission and the name of the manufacturer.
From where data/document is obtainable
Darman Afarin Noandish Afagh Company
What processes are involved for a request to access data/document
After the Submission of request and the confirmation, the information is provided by the company representative.