Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery (NOBLE-Laparo)
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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.
Condition or disease
Device: HEMOBLAST™ Bellows
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects undergoing laparoscopic abdominal, gynecological, or urological procedures that meet all of the inclusion criteria and none of the exclusion criteria.
Pre-operative 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.
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