HEMOBLAST Pilot Clinical Investigation

NCT02502019 | Completed Phase 1 Results DMC

• 1 other identifier: ETC 2015-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators

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

  Intraoperative

Secondary Outcomes (4)

• Hemostatic Within 6 Minutes

  Intraoperative

• Hemostasis Within 10 Minutes

  Intraoperative

• Hemostasis Within 3 Minutes

  Intraoperative

• Adverse Events

  6 +/- 2 weeks after implant

Study Arms (1)

HEMOBLAST

EXPERIMENTAL

All subjects will have the investigational device implanted

Device: HEMOBLAST Bellows

Interventions

HEMOBLAST Bellows DEVICE

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.

HEMOBLAST

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Sites (3)

University of Southern California

Los Angeles, California, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Location

Danville Orthopedic Clinic

Danville, Virginia, United States

Location

Results Point of Contact

• Title: Dr. William Spotnitz, Chief Medical Officer
• Organization: Biom'Up

wspotnitz@gmail.com

352-514-5009

Study Officials

• Linda Sher, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 17, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Locations

US (3)