| CTRI Number |
CTRI/2025/09/094598 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PINION PDO Knotless Suture |
|
Scientific Title of Study
|
A Prospective, Multicenter, Observational, Single-Arm, Open-Label, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Performance of PINION PDO Knotless Suture in Real-World Clinical Practice |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/Pinion PDO Knotless Suture_ Version 2.0.0_05-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India,Valsad
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, 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
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, 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 |
|
|
Source of Monetary or Material Support
|
| Meril Endo Surgery Pvt. Ltd
Meril Park, E1-E3,
Survey No. 135/2/B and 174/2,
Muktanand Marg, Chala, Vapi – 396191,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanandmarg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Mehta |
Excel Hospital |
12-15, 3rd Floor, Sheetal Shopping Square (Old L B Cinema, Bhatar Rd, near Fire Station, Surat, Gujarat 395001
Surat
GUJARAT |
9825147174
doc.manishmehta@gmail.com |
| Dr Rahul Lakhe |
Kalavati Hospital |
1st floor,Star Market, Jathar peth square, Mothi Umri Rd, Akola, Maharashtra 444005
Akola
MAHARASHTRA |
7276591594
drrahultlakhe@gmail.com |
| Dr Sandeep Wasnik |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
department of orthopaedic surgery, Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA |
7506662015
sandeep.wasnik@relianceada.com |
| DrKailash Patil |
Sancheti Institute for Orthopaedics and Rehabilitation |
Arthroplasty and arthroscopy sports injury department, 1st floor,11 and 12 Thube Park, 16, 16, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9890496959
drkailashpatil@yahoo.com |
| Dr Prashant Rahate |
Seven star hospital |
324 1 Great Nag Rd near Jagnade Square Rajendra Nagar Nandanvan Nagpur Maharashtra 440009
Nagpur
MAHARASHTRA |
9822464068
prashantrahate@yahoo.com |
| Dr Mehul Sukhadiya |
sumiran ivf & womens hospital |
46, Stadium Cross Rd, opp. Vipul Dudhiya, near Vodafone House, Swastik Society, Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT |
9825448148
mehulsukhadiya@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ACEAS-Independent Ethics Committee |
Approved |
| Ethics Committee Rahate Surgical Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE Kokilaben Dhirubhai Ambani Hospital |
Approved |
| Institutional Ethics Committee SIOR |
Approved |
| Lotus Superspeciality Hospital IEC |
Approved |
| Nirmal Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z480||Encounter for attention to dressings, sutures and drains, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. The Subject must be treated with PINION™ PDO suture with a soft suture approximation procedure.
2. The Subject must be willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee approved Informed Consent form
3. In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting. If the Subject is not able to write on behalf of the Subject, the Subjects LAR Legally acceptable representative can fill out the informed consent.
4. Subject must be willing to undergo soft tissue repair and be able to undergo all other study procedures as outlined in this protocol.
5. The subject is willing and able to comply with postoperative scheduled clinical evaluations
|
|
| ExclusionCriteria |
| Details |
Participants are not suitable for anesthesia or
endovascular surgery, such as those with severe
respiratory, heart, lung, liver, kidney disease or
coagulation disorders such as hemophilia.
Participants undergoing neural tissue procedures and tendinous tissue repair or surgery.
Participants scheduled for ophthalmic surgery and
microsurgery.
Participants undergoing urinary tract and biliary tract surgery where prolonged contact with salt solutions is anticipated.
Participants with a history of HIV or any other systemic infections.
Participants with ongoing sepsis or septicemia, ongoing bacterial infection or on antibiotic treatment other than
prophylaxis antibiotics given prior to and post-surgery.
Participants with a history of prior surgery within the past one month with Surgical Site Infection.
Pregnant or breast-feeding women.
Participants who are unwilling or unable to sign the Informed Consent Document.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Surgical site infection
2.wound complications
3.Adverse event
4.Intraoperative complications |
1. Time Frame: Intra-operative
2.Time Frame: Intra-operative
3.Time Frame: 7 days ± 2 days, 30 days ±7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Length of hospital stay
2.Re-admission rate
3.Ease of Use |
1.Time Frame: Post-operative , 7 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days & 6 months ± 30 days
2.Time Frame: Intra-operative
3.Time Frame: Discharge, 7
days ± 2 days,30 days ± 7 days |
|
|
Target Sample Size
|
Total Sample Size="189"
Sample Size from India="189"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Title :A prospective, single-arm, multi-centre, observational, post marketing surveillance study to evaluate the safety and performance of PINION™ PDO Knotless Suture in real-world settings
Short Title PINION PDO PMS
Study device PINION PDO Absorbable Poly Knotless Suture
Indication PINION PDO Knotless Suture is indicated for use in soft tissue approximation where absorbable sutures use is appropriate.
Objective This study aims to evaluate the safety and performance of PINION PDO Knotless sutures in real-world settings. To evaluate the suture’s ability to significantly reduce surgical time. Minimize blood loss during procedures Decrease overall surgical difficulty. Uniform tension across the wound.
Study Design A prospective, single-arm, multi-centre, observational, postmarketing surveillance study
Rationale of the Study Knotless sutures are of fundamental importance in surgical outcomes. PINION™ PDO Knotless Suture contains bidirectional oriented barbs to anchor tissues and does not require knots to approximate opposing edges of a wound. Tying knots on the barbed section of the material will damage the barbs and potentially reduce the suture tensile strength and barb effectiveness. Hence, the present study is to evaluate the safety and performance of a sterile, synthetic, absorbable monofilament suture comprised of Poly in the fixation of soft tissue |