| CTRI Number |
CTRI/2025/11/097681 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MERIFEIM(TM) Absorbable Gelatin Sponge – A Safe Surgical Bleeding Control Sponge. |
|
Scientific Title of Study
|
A prospective, observational, single-arm, multicenter, open-label, post-market clinical follow-up study to evaluate the safety and performance of MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. in a real-world setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/MERIFEIM Endoscopic Tampon V 1.0.0 dated 01-03-25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Kumar Shetty |
| Designation |
Additional General Manager– Product Performance Engineering and PMCF |
| Affiliation |
Meril LIfe Science Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd.
Survey No. 135/139, Bilakhia House
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 Kiran Kumar Shetty |
| Designation |
Additional General Manager– Product Performance Engineering and PMCF |
| Affiliation |
Meril LIfe Science Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd.
Survey No. 135/139, Bilakhia House
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 Kiran Kumar Shetty |
| Designation |
Additional General Manager– Product Performance Engineering and PMCF |
| Affiliation |
Meril LIfe Science Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd.
Survey No. 135/139, Bilakhia House
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 & 174 2,
Muktanand Marg, Chala, Vapi,
Valsad, Gujarat– 396191. |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt. Ltd, |
| Address |
Survey No. 135/139, Bilakhia House
Muktanand Marg, Chala,
Vapi – 396191, Gujarat,
India |
| Type of Sponsor |
Other [Medical Device] |
|
|
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 Madan Mohan Jha |
Evan Multispeciality Hospital |
Department of Laparoscopy 1st floor Bhopa Rd, Mustafabad, Uttar Pradesh 251001
Muzaffarnagar
UTTAR PRADESH |
9540795525
drmadanmjha@yahoo.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 |
7055510049
anand.agrawalll@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
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
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject can be an adult age men or women.
2. Subject is willing to be treated with MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. as a hemostatic device in endoscopic or laparoscopic key-hole surgeries when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical.
3. Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
4. Subject is willing and able to comply with post-procedure scheduled clinical evaluations. |
|
| ExclusionCriteria |
| Details |
1. Subjects who do not require MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. intraoperative hemostatic device, in endoscopic or laparoscopic key-hole surgeries wherein pressure, ligature, and other conventional procedures are ineffective or impractical for control of capillary, venous, and arteriolar bleeding.
2. Pregnant or lactating women.
3. Subjects having infections.
4. Subjects having known allergies to collagen.
5. Subjects at risk of embolization and infected wounds or wounds with an inflammatory secretion.
6. Subjects already using methyl methacrylate adhesives.
7. Subjects having coagulation disorders. |
|
|
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. Adverse Events
3. Device success |
1. Time Frame: Intra-operative
2. Time Frame: Discharge, 7 days, 15 days, 1 month
3. Time Frame: Intra-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemostatic Handling Characteristics.
2. Blood Loss
3. Length of Hospital Stay.
4. Operative time
5. Number of Participants Who Require Alternative Hemostatic Agents at 6 Minutes.
6. Blood transfusion.
7. Postoperative pain
|
1.Time Frame: Intra-operative
2.Time Frame: Intra-operative
3. Time Frame: Admission to Discharge
4. Time Frame: Intra-operative
5. Time Frame: Intra-operative
6. Time Frame: Intra-operative
Time Frame: Discharge, 7 days, 15 days, 1 month |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
30/11/2025 |
| 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)
|
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
|
Study Name: A prospective, observational, single-arm, multicenter, open-label, post-market clinical follow-up study to evaluate the safety and performance of MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. in a real-world setting.
Indication: MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge is indicated in surgical procedures as a hemostatic device when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical.
Objective: The study aims to evaluate the safety and performance of MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. for hemostasis in various endoscopic or laparoscopic key-hole surgeries where conventional methods, such as pressure or ligature, are insufficient for controlling bleeding.
Rationale of the Study Endoscopic procedures often involve bleeding risks, necessitating effective hemostatic agents to ensure procedural safety and Subject recovery. MERIFEIM™ Endoscopic Tampon Absorbable Gelatin Sponge U.S.P. is designed to provide rapid and efficient hemostasis in endoscopic surgeries, particularly in mucosal and minimally invasive interventions. The product’s absorbable nature minimizes the need for removal, reducing procedural complexity and enhancing Subject comfort. This study aims to evaluate the safety and performance of MERIFEIM™ in real-world clinical settings. The key parameters include time to hemostasis (TTH), device success, handling characteristics, operative time, length of hospital stay, blood transfusion, and requirement of an alternate hemostatic agent. Additionally, pain scores, blood loss, and adverse events will be assessed during the follow-up periods. A prospective, observational, single-arm, multicenter, open-label, post-market clinical follow-up study will be conducted, enrolling Subjects undergoing endoscopic procedures with bleeding risks. The findings will help validate its performance, potentially broadening its clinical applications and improving surgical hemostasis management. |