Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Surgical Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734535
• Other study ID #: ETC-2020-001
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: February 5, 2024

Study information

• Verified date: April 2024
• Source: Dilon Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Surgical Bleeding

Intervention

Device:
• HEMOBLAST™ Bellows
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
• absorbable gelatin sponge with thrombin
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dilon Technologies Inc.	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemostasis within 6 minutes	Proportion of subjects achieving hemostasis within 6 minutes for HEMOBLAST™ subjects compared to G+T subjects	immediately after procedure
Other	Operative time	Operative time for HEMOBLAST™ subjects compared to G+T subjects	immediately after procedure
Other	Length of stay	Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects	From procedure to discharge, estimated average = 36 hours
Other	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
Primary	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	Adverse events (AE)	the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.	3 months follow-up