Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Sponsored by Biom'Up France SAS
About this trial
Last updated 5 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the Participation Requirements?
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.
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