Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgical Bleeding
• Intervention / Treatment: Device: HEMOBLAST™ Bellows; Device: absorbable gelatin sponge with thrombin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 900033
      • University of Southern California
  • Indiana
    • Carmel, Indiana, United States, 13225
      • Indiana Spine Group
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Virginia
    • Danville, Virginia, United States, 24511
      • Spectrum Medical Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: investigational; HEMOBLAST™ Bellows	Device: HEMOBLAST™ Bellows; Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
Active Comparator: control; absorbable gelatin sponge with thrombin	Device: absorbable gelatin sponge with thrombin; Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Unanticipated Adverse Device Effect (UADE)	incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).	3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AE)	the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.	3 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis within 6 minutes	Proportion of subjects achieving hemostasis within 6 minutes for HEMOBLAST™ subjects compared to G+T subjects	immediately after procedure
Operative time	Operative time for HEMOBLAST™ subjects compared to G+T subjects	immediately after procedure
Length of stay	Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects	From procedure to discharge, estimated average = 36 hours
Blood transfusions	Number of units of blood transfused intraoperatively for HEMOBLAST™ subjects compared to G+T subjects	From procedure to discharge, estimated average = 36 hours

Collaborators and Investigators

• Sponsor: Dilon Technologies Inc.
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Joseph Schwab, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elective, spine surgery, bleeding control, hemostasis
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemostatics; Coagulants; Thrombin; Gelatin Sponge, Absorbable
• Other Study ID Numbers: ETC-2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes