NCT03873168

Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Biom'Up France SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

Detailed description

A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Conditions

• Hemostasis

Interventions

Type	Name	Description
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 gynecological, urological, vascular, ENT and head and neck surgeries.

Timeline

• Start date: 2019-05-09
• Primary completion: 2021-07-27
• Completion: 2021-07-27
• First posted: 2019-03-13
• Last updated: 2021-08-30

Locations

9 sites across 3 countries: Austria, France, Germany

Regulatory

• FDA-regulated device study