Prospective, multi-center, single-arm, interventional, post-market clinical study to evaluate safety and performance of absorbable, gelatin-based hemostat in patients undergoing abdominal, anorectal, dental, ENT, Genito-urinary, gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery when controlling bleeding by standard surgical techniques is ineffective and/or impractical - NI

Aegis Lifesciences Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

研究概览

暂无简介。

•1. The patient is 18 years of age or older
•2. The patient will undergo one or more of the following procedures: abdominal, anorectal, dental, ENT, Genito-urinary,gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery
•3. Patient or their guardian is willing to sign Informed Consent Form (ICF)
•4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up

•Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care) or is lactating
•Patient is allergic to collagen derived products or any other materials used in absorbable gelatine sponge and powder
•Patient has an active infection at the surgical site
•The use of hemostat is contraindicated for the patient
•Patient has known bleeding disorder (including thrombocytopenia (less than 100000 platelet count) thrombasthenia hemophilia or von Willebrand disease)
•Patient has received antibiotic solutions or powders at the intended application site
•Patient has undergone surgery at the intended application site less than or equal to 6 months before the current surgical procedure
•Patient is unavailable for followup
•Patient is currently participating in another clinical study

发起方

Aegis Lifesciences Pvt. Ltd.