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

Biom'Up France SAS8 sites in 3 countries102 target enrollmentMay 16, 2019

ConditionsHemostasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hemostasis
Sponsor: Biom'Up France SAS
Enrollment: 102
Locations: 8
Primary Endpoint: Achievement of Hemostasis
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2019

End Date

August 26, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biom'Up France SAS

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Achievement of Hemostasis

Time Frame: Intraoperatively, expected within 3-10 minutes of application

The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.

Secondary Outcomes

Re-operation due to bleeding(Post-operatively, expected within 1-30 days of the surgical procedure)
Re-bleeding at Target Bleeding Site(Intraoperative, prior to surgical closure of the subject)