Status:
COMPLETED
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Lead Sponsor:
Biom'Up France SAS
Conditions:
Hemostasis
Eligibility:
All Genders
18+ years
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, gynecolog...
Eligibility Criteria
Inclusion
- Pre-operative
- 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
- 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
Key Trial Info
Start Date :
May 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2020
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03873181
Start Date
May 16 2019
End Date
August 26 2020
Last Update
December 4 2020
Active Locations (8)
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1
University Hospital Salzburg
Salzburg, Austria
2
Hôpital Beaujon
Clichy, France
3
CHU Grenoble
Grenoble, France
4
Hôpital Saint Jospeh
Paris, France, 75674