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
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- 1.Time to Hemostasis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The Subject of age 18 and above, irrespective of gender willing to undergo intervention with Merifeim.
- •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.
- •Subjects with the absence of any prior surgical interventions at the designated site.
- •Subjects with the absence of active bleeding preoperatively, as determined by clinical symptoms, vital signs, and laboratory examination findings.
- •The Subject is willing and able to comply with postoperative scheduled clinical evaluations.
- •Subjects who are able to give voluntary, written informed consent to participate in this PMCF and from whom consent has been obtained.
排除标准
- •Subjects undergoing closure of skin incisions will be excluded, because it may interfere with the healing of skin edges.
- •Subjects with known allergies to collagen.
- •Subjects undergoing treatment in intravascular compartments will be excluded due to the risk of embolization.
- •If subject have any infected wounds or wounds with an inflammatory secretion.
- •If subject has any infection.
- •Subjects treating with methyl methacrylate adhesives, autologous blood salvage circuits.
结局指标
主要结局
1.Time to Hemostasis
时间窗: 1.Time Frame: Intra-operative | 2.Time Frame: Post | operative 7days, 15days and 1 month | 3.Time Frame: up to 6 minutes post procedure
2.Device-related Adverse events
时间窗: 1.Time Frame: Intra-operative | 2.Time Frame: Post | operative 7days, 15days and 1 month | 3.Time Frame: up to 6 minutes post procedure
3.Success rate
时间窗: 1.Time Frame: Intra-operative | 2.Time Frame: Post | operative 7days, 15days and 1 month | 3.Time Frame: up to 6 minutes post procedure
次要结局
- 1.Intra-operative Blood Loss(2.Post-operative pain score)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd