Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

NCT04734535 | Completed DMC FDA Device

• 1 other identifier: ETC-2020-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Surgical Bleeding

Keywords

Elective, spine surgery, bleeding control, hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events (AE)

  3 months follow-up

Other Outcomes (4)

• Hemostasis within 6 minutes

  immediately after procedure

• Operative time

  immediately after procedure

• Length of stay

  From procedure to discharge, estimated average = 36 hours

Study Arms (2)

investigational

EXPERIMENTAL

HEMOBLAST™ Bellows

Device: HEMOBLAST™ Bellows

control

ACTIVE COMPARATOR

absorbable gelatin sponge with thrombin

Device: absorbable gelatin sponge with thrombin

Interventions

HEMOBLAST™ Bellows DEVICE

Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows

investigational

absorbable gelatin sponge with thrombin DEVICE

Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin

control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dilon Technologies Inc.: lead
• Syneos Health: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 900033, United States

Location

Indiana Spine Group

Carmel, Indiana, 13225, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spectrum Medical Inc

Danville, Virginia, 24511, United States

Location

MeSH Terms

Interventions

Gelatin Sponge, Absorbable

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Study Officials

• Joseph Schwab, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data blinding to Sponsor, Independent Data Monitoring Committee, FDA reviewer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 2, 2021
• Study Start: March 8, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)