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Clinical Trials/NCT04471350
NCT04471350WithdrawnNot Applicable

Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery

Biom'Up France SAS1 site in 1 countryStarted: June 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Achievement of Hemostasis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 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 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

Outcomes

Primary Outcomes

Achievement of Hemostasis

Time Frame: Intraoperatively, expected within 3-10 minutes of application

The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.

Secondary Outcomes

  • Re-operation due to bleeding(Post-operatively, expected within 1-28 days of the surgical procedure)
  • Incidence of Serious Adverse Device Effects (SADEs)(4 weeks +/- 2 weeks)
  • Re-bleeding at Target Bleeding Site(Intraoperative, prior to surgical closure of the subject)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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