Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
NCT ID: NCT03873181
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2019-05-16
2020-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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HEMOBLAST™ Bellows
Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in laparoscopic abdominal, gynecological, or urological surgeries.
Eligibility Criteria
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Inclusion Criteria
* Patient is willing and able to give prior written informed consent for investigation participation;
* Patient is 18 years of age or older.
* 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 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
18 Years
ALL
No
Sponsors
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Biom'Up France SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Tim Vilz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Locations
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University Hospital Salzburg
Salzburg, , Austria
Hôpital Beaujon
Clichy, , France
CHU Grenoble
Grenoble, , France
Hôpital Saint Jospeh
Paris, , France
University Hospital Bonn
Bonn, , Germany
Kliniken der Stadt Koln, Krankenhaus Merheim
Cologne, , Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Countries
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Other Identifiers
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ETC 2018-002
Identifier Type: -
Identifier Source: org_study_id