Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery

Completed

• Conditions: Hemostasis

• Registration Number: NCT03873181
• Lead Sponsor: Biom'Up France SAS

Brief Summary

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.

Detailed Description

A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery. Up to 100 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-05-16
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patient is undergoing a non-emergent laparoscopic abdominal, gynecological, or urological surgery
• Patient is willing and able to give prior written informed consent for investigation participation;
• Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

• Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
• The TBS(s) has been treated with HEMOBLAST™ Bellows and the HEMOBLAST™ Bellows Laparoscopic Applicator as per their instructions for use.

Exclusion Criteria

• Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
• Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
• Patient has religious or other objections to porcine, bovine, or human components;
• Patient has any significant coagulation disorder;
• Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
• Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of Hemostasis	Intraoperatively, expected within 3-10 minutes of application	The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.

Secondary Outcome Measures

Name	Time	Method
Re-operation due to bleeding	Post-operatively, expected within 1-30 days of the surgical procedure	The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
Re-bleeding at Target Bleeding Site	Intraoperative, prior to surgical closure of the subject	The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows

Trial Locations

Locations (8)

Hôpital Saint Jospeh; 🇫🇷 Paris, France

University Hospital Salzburg; 🇦🇹 Salzburg, Austria

Hôpital Beaujon; 🇫🇷 Clichy, France

CHU Grenoble; 🇫🇷 Grenoble, France

University Hospital Bonn; 🇩🇪 Bonn, Germany

Asklepios Klinik Barmbek; 🇩🇪 Hamburg, Germany

Kliniken der Stadt Koln, Krankenhaus Merheim; 🇩🇪 Köln, Germany

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt am main, Germany