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.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject can be an adult age men or women.
- •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.
- •Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
- •Subject is willing and able to comply with post-procedure scheduled clinical evaluations.
排除标准
- •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.
- •Pregnant or lactating women.
- •Subjects having infections.
- •Subjects having known allergies to collagen.
- •Subjects at risk of embolization and infected wounds or wounds with an inflammatory secretion.
- •Subjects already using methyl methacrylate adhesives.
- •Subjects having coagulation disorders.
研究者
Dr Kiran Kumar Shetty
Meril LIfe Science Pvt. Ltd