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

Dilon Technologies Inc.5 sites in 1 country60 target enrollmentMarch 8, 2021

ConditionsSurgical Bleeding

Overview

Phase: N/A
Intervention: Not specified
Conditions: Surgical Bleeding
Sponsor: Dilon Technologies Inc.
Enrollment: 60
Locations: 5
Primary Endpoint: Incidence of Unanticipated Adverse Device Effect (UADE)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2021

End Date

February 5, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dilon Technologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

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