HEMOBLAST Pilot Clinical Investigation

Hemostasis Clinical Trial

Official title: Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries

Status Completed

Clinical Trial Summary

The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.

Clinical Trial Description

HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.

This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites.

The subjects will be followed at hospital charge and 6 weeks postoperatively.

The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.

Secondary endpoints of this clinical investigation consist of:

• Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application;

• Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application;

• Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and

• Incidence of adverse events through final follow-up. ;

Related Conditions & MeSH terms

• Hemostasis

• NCT number: NCT02502019
• Study type: Interventional
• Source: Biom'Up SA
• Status: Completed
• Phase: Phase 1
• Start date: August 2015
• Completion date: March 2016