Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery

Hemostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04471350
• Other study ID #: ETC 2018-004
• Status: Withdrawn
• Start date: June 2021
• Est. completion date: August 2022

Study information

• Verified date: August 2021
• Source: Biom'Up France SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Pre-operative 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

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• HEMOBLAST™ Bellows
Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.

Locations

Country	Name	City	State
France	L'Hôpital privé du Confluent	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Biom'Up France SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of Hemostasis	The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.	Intraoperatively, expected within 3-10 minutes of application
Secondary	Incidence of Serious Adverse Device Effects (SADEs)	The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows	4 weeks +/- 2 weeks
Secondary	Re-bleeding at Target Bleeding Site	The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows	Intraoperative, prior to surgical closure of the subject
Secondary	Re-operation due to bleeding	The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows	Post-operatively, expected within 1-28 days of the surgical procedure