Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urolog… (NCT03873181) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Austria, France, Germany102 participantsStarted 2019-05-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Achievement of Hemostasis
Timeframe: Intraoperatively, expected within 3-10 minutes of application