| CTRI Number |
CTRI/2025/08/092810 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MERIFEIM Standard and MERIFEIM No-Touch Pack (Standard) are a rectangular block of
Absorbable Gelatin Sponge U.S.P |
|
Scientific Title of Study
|
MERIFEIM(TM) Standard and MERIFEIM(TM) Standard (No-Touch Pack)-PMCF Study: A prospective, observational, single-arm, open-label, multi-centre, post-market clinical follow-up
study to evaluate the Safety and Performance of the MERIFEIM(TM) Standard and MERIFEIM(TM) Standard (No-Touch Pack) Absorbable Gelatin Sponge U.S.P. in a real-world setting |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MES/MERIFEIM Standard, V1.1.0, 22-Sept-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 BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191
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 BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191
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 BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191
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 & 174,2,
Muktanand Marg, Chala, Vapi,
Valsad, Gujarat– 396191 |
|
|
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
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madan Mohan Jha |
Evan Multispeciality Hospital |
Department of Laparoscopy 1st floor Bhopa Rd, Mustafabad, Uttar Pradesh 251
Muzaffarnagar
UTTAR PRADESH
Muzaffarnagar
UTTAR PRADESH |
9540795525
drmadanmjha@yahoo.com |
| Dr Mohammad Mubeen |
FAH Super Speciality Hospital |
Ground Floor, Department of Cardio-Surgery, FAH Super Speciality Hospital, Amrapali Yojna, IIM Road, near Shahid Smarak Park, Lucknow, Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH |
8800231177
Sayyam05@gmail.com |
| Dr Anand Agrawal |
G.R Hospital |
Department of Laparoscopic, Ground Floor 1180, Arya Nagar Rd, Arya Nagar, Kosi Kalan, Uttar Pradesh 281403
Mathura
UTTAR PRADESH
Mathura
UTTAR PRADESH |
7055510049
anand.agrawalll@gmail.com |
| Dr Pradeep Bansode |
Gunjkar Multispeciality Hospital |
First Floor,General Surgeon,Spine road, Shivtej Nagar,,Chikhali Pune,411019,Maharashtra, India
Pune
MAHARASHTRA |
7020733747
drpradeep.gunjkarhospital@gmail.com |
| Dr Dhanashree Dawane |
MTEs Sanjeevan Hospital |
Second Floor, Consultant Genecology,FP23,off Karve Road, Kashibai Khilare Path, Pune-411004,Maharshtra India
Pune
MAHARASHTRA |
9403733917
dr.dhana88@gmail.com |
| Dr KG Somashekara |
sapthagiri Instittute of Medical Science and Research Centre |
ENT Department 1st floor, 15, Chikkasandra Hesarghatta Main Road, Bengaluru, Karnataka-560090, India
Bangalore
KARNATAKA |
9844024597
cepodemxp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| IEC SANGVI MULTISPECIALITY HOSPITAL |
Approved |
| IEC Sapthagiri Institute of Medical Science and Reasearch Centre |
Approved |
| IEC- Atharva Multispecialty Hospital and Research Centre |
Approved |
| Kusum Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.The Subject of age 18 and above, irrespective of gender willing to undergo intervention with Merifeim.
2. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
3.In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting.
4. Subjects with the absence of any prior surgical interventions at the designated site.
5. Subjects with the absence of active bleeding preoperatively, as determined by clinical symptoms, vital signs, and laboratory examination findings.
6. The Subject is willing and able to comply with
postoperative scheduled clinical evaluations.
7. Subjects who are able to give voluntary, written informed consent to participate in this PMCF and from whom consent has been obtained |
|
| ExclusionCriteria |
| Details |
1. Subjects undergoing closure of skin incisions will be excluded, because it may interfere with the healing of skin edges.
2. Subjects with known allergies to collagen.
3. Subjects undergoing treatment in intravascular
compartments will be excluded due to the risk of
embolization.
4. If subject have any infected wounds or wounds with an inflammatory secretion.
5. If subject has any infection.
6. Subjects treating with methyl methacrylate adhesives, autologous blood salvage circuits. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to Hemostasis
2.Device-related Adverse events
3.Success rate |
1.Time Frame: Intra-operative
2.Time Frame: Post
operative 7days, 15days and 1 month
3.Time Frame: up to 6 minutes post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intra-operative Blood Loss
2.Post-operative pain score
3.Length of hospital stay
4.Ease of handling |
1.Time Frame: Intra-operative
2.Time Frame: Post-operative 7 days, 15days & 1
month
3.Time Frame: From admission to discharge
4.Time Frame: Intra-operative |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/08/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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)
|
Study Name: A prospective, observational, single-arm, open-label, multi-centre post-market clinical follow-up study to evaluate the Safety and Performance of the MERIFEIM™ Standard and MERIFEIM™ Standard (No-Touch Pack) Absorbable Gelatin Sponge U.S.P. in a real-world setting.
Short Title: MERIFEIM Standard and MERIFEIM Standard (No-Touch Pack)
Protocol ID, Version & Date: MES/MERIFEIM Standard and MERIFEIM Standard (No-Touch Pack)_Version 1.1.0_22-Sept-2025
Study Device: MERIFEIM™ Standard and MERIFEIM™ Standard (No-Touch Pack) Absorbable Gelatin Sponge U.S.P.
Indication: MERIFEIM™ Absorbable Gelatin Sponge (both Standard and NoTouch Pack versions) is a hemostatic device used in surgeries when traditional bleeding control methods like pressure or ligature are ineffective or impractical to apply. It helps control bleeding from capillaries, veins, and arterioles.
Objective: The study aims to evaluate the safety and performance of MERIFEIM™ Standard and MERIFEIM™ Standard (No-Touch Pack) Absorbable Gelatin Sponge U.S.P. for hemostasis in various surgeries where conventional methods, such as pressure or ligature, are insufficient for controlling bleeding.
Rationale of the Study Hemorrhage remains the primary cause of death and the second leading cause of pre-hospital mortality in trauma cases. Severe blood loss reduces circulating volume, leading to inadequate tissue oxygenation (shock) and complications including hypothermia, coagulopathy, and acidosis—all associated with higher morbidity and mortality rates. Prompt hemorrhage control is therefore crucial to minimize blood loss. The body’s natural response to vessel injury involves clot formation, where platelets adhere to the exposed subendothelial matrix and aggregate to create an initial plug. This plug is subsequently reinforced by a fibrin biopolymer hydrogel matrix generated through the coagulation cascade. However, severe traumatic injuries require medical intervention to stop bleeding effectively.
External hemorrhage management typically involves tourniquets, direct pressure application, and/or hemostatic dressings. The specific need for improved hemorrhage control in combat casualties has driven significant advancements in hemostatic dressing technology beyond conventional gauze. MERIFEIM™ Absorbable Gelatin Sponge U.S.P. is one such device intended for homeostatic use by applying to a bleeding surface. MERIFEIM™ Absorbable Gelatin Sponge U.S.P. is a hemostatic device used in surgery to control bleeding from capillaries, veins, and arterioles. It can be applied dry or moistened with a sterile saline solution. It’s intended for situations where standard bleeding control methods, like pressure or ligation, are insufficient or unsuitable. While effective on its own, MERIFEIM™ can also be used in conjunction with thrombin to enhance hemostasis. This study aims to assess the safety performance, and outcomes of the MERIFEIM™ Standard and MERIFEIM™ Standard (NoTouch Pack) Absorbable Gelatin Sponge U.S.P. as an effective hemostatic device in surgeries. |