Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery

Withdrawn

• Conditions: Hemostasis

• Registration Number: NCT04471350
• Lead Sponsor: Biom'Up France SAS

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 Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2021-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-06
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of Hemostasis	Intraoperatively, expected within 3-10 minutes of application	The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.

Secondary Outcome Measures

Name	Time	Method
Re-operation due to bleeding	Post-operatively, expected within 1-28 days of the surgical procedure	The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
Incidence of Serious Adverse Device Effects (SADEs)	4 weeks +/- 2 weeks	The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows
Re-bleeding at Target Bleeding Site	Intraoperative, prior to surgical closure of the subject	The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows

Trial Locations

Locations (1)

L'Hôpital privé du Confluent; 🇫🇷 Nantes, France