Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Completed · Not applicable

Conditions studied: Surgical Bleeding

In brief

The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.

Key facts

Study ID: NCT04734535
Run by: Dilon Technologies Inc.
People needed: 60
Starts: 2021-03-08
Expected to finish: 2024-02-05
Last updated by the study team: 2024-04-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is undergoing open, elective, spine surgery
Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation
Subject is 22 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 hemostasis are ineffective or impractical
Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3

You may not qualify if…

Subject is undergoing an emergency surgical procedure
Subject is undergoing a laparoscopic surgery
Subject is undergoing a cervical spine surgery
Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding
Subject has a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery
Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery
Subject receiving antiplatelet medications within 5 days prior to surgery
Subject receiving aspirin within 7 days prior to surgery
Subject has an active or suspected infection at the surgical site
Subject has had or has planned to receive 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 a known sensitivity or allergy to Gadolinium
The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations
Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g., metal implants, spinal cord stimulator, etc. not suited to MRI)
Subject has American Society of Anesthesiologists classification of > 4
Subject has a life expectancy of less than 3 months
Subject has a documented severe congenital or acquired immunodeficiency
Subject has religious or other objections to porcine, bovine, or human components
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
Per investigator opinion subject is unable to fully cooperate with the study protocol.
The product will be placed in at the site where the dura is open
The product will be placed in the intradural or cranial space

Where it is running

University of Southern California — Los Angeles, California, United States
Indiana Spine Group — Carmel, Indiana, United States
Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Spectrum Medical Inc — Danville, Virginia, United States

Full record on ClinicalTrials.gov

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