| CTRI Number |
CTRI/2024/04/065476 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective, Post Marketing Clinical Follow-up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
SUTURE PMCF STUDY(Sutures are primarily
used to oppose tissues together to assist and accelerate the recovery process after an incident
or surgical operation) |
|
Scientific Title of Study
|
A retrospective, multicenter,
observational, real-world post-market clinical follow-up study to evaluate the safety and
performance of MEGASORBâ„¢ surgical suture used for general soft tissue approximation and/or
ligation, including use in ophthalmic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/MEGASORB surgical suture PMCF Study,V1.0.0 19 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance and Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance and Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance and Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo-Surgery Pvt. Ltd. Third Floor, E1-E3 Meril Park, Survey No. 135,2,B & 174.2, Muktanand Marg, Chala Vapi – 396191, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala,
Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Sharan |
Apex Hospital |
General surgeon,2nd floor, SP-4 and 6, Central Road, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, Rajasthan 302017
Jaipur
RAJASTHAN |
8005579306
dramitsharan@yahoo.com |
| Dr Akshay Solanki |
Yash Aman Hospital |
General surgeon Ground floor, Kishore bag road, Near Bhumiya Ji ka Mandir, Mandore, Jodhpur, Rajasthan 342002
Jodhpur
RAJASTHAN |
9828582914
Drasolanki@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients who underwent surgical
experience like general soft tissue approximation and/or
ligation, including use in ophthalmic surgery using
MEGASORBâ„¢ Surgical suture.
- Patients who have completed a minimum of 03 month
after the surgery using MEGASORBâ„¢ surgical suture |
|
| ExclusionCriteria |
| Details |
Since this is a retrospective review of data, there are no
specific exclusion Criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Wound disruptions
2. Intraocular Pressure (IOP) following hypotonyrelated complications
3. Intra-operative complication
4. Surgical Site Infection
5. Time to wound closure |
1. Time frame: Discharge, through 7 days, through 30 days
2. Time Frame: Pre-operative,
postoperative, through 7 days, through 30 days
3. Time Frame: During
Procedure
4. Time Frame: Discharge,
through 7 days, through 30 days
5. Time Frame: Intra-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Wound healing
2. Length of hospital stay
3. Re-intervention
4. Surgical Site Infection
5. Adverse events related to suture
|
1. Time Frame: Through 7 days,
through 30 days, through 3 months
2. Time Frame: Hospital
admission to discharge
3. Time Frame: Through 7 days,
through 30 days, through 3 months
4. Time Frame: Discharge,
through 7 days, through 30 days, through 3 months
5. Time Frame:
Through 7 days, through 30 days, through 3 months
6. |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
MEGASORBSURGICAL SUTURE PMCF STUDY: A retrospective, multicenter,
observational, real-world post-market clinical follow-up study to evaluate the safety and
performance of MEGASORBâ„¢ surgical suture used for general soft tissue approximation and/or
ligation, including use in ophthalmic surgery
Study Design: A retrospective, multicenter, observational, real-world postmarket clinical follow-up study
Patient Population: All consecutive patients who underwent surgical experience like
general soft tissue approximation and/or ligation, including use
in ophthalmic surgery using MEGASORBâ„¢ Surgical suture,
and have completed a minimum of 3-month follow-up.
Objective: To evaluate the safety and performance of MEGASORBâ„¢
surgical suture used for general soft tissue approximation and/or
ligation, including use in ophthalmic surgery cutting in realworld patients.
|