Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery

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

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

Study Overview

• Status: Withdrawn
• Conditions: Hemostasis
• Intervention / Treatment: Device: HEMOBLAST™ Bellows

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • L'Hôpital Privé du Confluent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing spine surgery that meet all of the inclusion criteria and none of the exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Biom'Up France SAS
• Investigators: Principal Investigator: Pierre-Marie Longis, MD, L'Hôpital Privé du Confluent

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ETC 2018-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No