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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

ETC 2018-002

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

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