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

Biom'Up France SAS3 sites in 1 country27 target enrollmentAugust 2015

ConditionsHemostasis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hemostasis
Sponsor: Biom'Up France SAS
Enrollment: 27
Locations: 3
Primary Endpoint: Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

March 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biom'Up France SAS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•• Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery;
•Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
•Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and
•Subject is 21 years of age or older.
•Subject does not have an active or suspected infection at the surgical site;
•Subject in whom the Investigator is able to identify a target bleeding site (TBS) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and
•Subject has a TBS with an SBSS score of 1, 2, or 3.

Exclusion Criteria

•• Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
•Subject is undergoing a spinal surgical procedure;
•Subject is undergoing a neurologic surgical procedure;
•Subject is undergoing an emergency surgical procedure;
•Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
•Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter and/or International Normalized Ratio \> 1.5 within 4 weeks of surgery;
•Subject had chronic corticosteroid use within 2 weeks prior to surgery;
•Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery;
•Subject has an active or suspected infection at the surgical site;
•Subject has had or has planned any organ transplantation;