Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery

NCT04471350 | Withdrawn FDA Device

• 1 other identifier: ETC 2018-004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Re-operation due to bleeding

  Post-operatively, expected within 1-28 days of the surgical procedure

Interventions

HEMOBLAST™ Bellows DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Sites (1)

L'Hôpital privé du Confluent

Nantes, France

Location

Study Officials

• Pierre-Marie Longis, MD

  L'Hôpital privé du Confluent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)