Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

Launched by BIOM'UP FRANCE SAS · Mar 11, 2019

Keywords

ClinConnect Summary

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 open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Gender

ALL

Eligibility criteria

• Pre-operative Inclusion Criteria:
• • Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular 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 HEMOBLASTTM Bellows 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