Status:
WITHDRAWN
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Lead Sponsor:
Biom'Up France SAS
Conditions:
Hemostasis
Eligibility:
All Genders
18+ years
Brief Summary
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
Detailed Description
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.
Eligibility Criteria
Inclusion
- Pre-operative
- Patient is undergoing a non-emergent spine 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 per instructions for use.
Exclusion
- 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 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04471350
Start Date
June 1 2021
End Date
August 1 2022
Last Update
August 30 2021
Active Locations (1)
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1
L'Hôpital privé du Confluent
Nantes, France