HEMOBLAST Pilot Clinical Investigation

Biom'Up

Status and phase

Completed

Phase 1

Conditions

Hemostasis

Treatments

Device: HEMOBLAST Bellows

Study type

Interventional

Funder types

Industry

Identifiers

NCT02502019

ETC 2015-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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;
- Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- Subject has ASA classification of > 4;
- Subject has a life expectancy of less than 3 months;
- Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
- Subject has a documented severe congenital or acquired immunodeficiency;
- Subject has religious or other objections to porcine or bovine components;
- Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant;
- Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.