MERIFEIM(TM) Absorbable Gelatin Sponge A Safe Surgical Bleeding Control Sponge.

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. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/11/097681

Enrollment

Registered

2025-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Time to Hemostasis 2. Adverse Events 3. Device successTimepoint: 1. Time Frame: Intra-operative 2. Time Frame: Discharge, 7 days, 15 days, 1 month 3. Time Frame: Intra-operative	—

Secondary

Measure	Time frame
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 Timepoint: 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	—

Measure

Time frame

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 Timepoint: 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

—

Countries

India

Contacts

Public ContactDr Kiran Kumar Shetty

Meril LIfe Science Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026