Clinical trial NCT04734535: Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
Official title: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Bleeding
Keywords: Elective, spine surgery, bleeding control, hemostasis
Lead sponsor: Dilon Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2021-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Incidence of Unanticipated Adverse Device Effect (UADE)
timeFrame: 3 months follow-up
Secondary outcomes:
measure: Adverse events (AE)
timeFrame: 3 months follow-up
Other outcomes:
measure: Hemostasis within 6 minutes
timeFrame: immediately after procedure
measure: Operative time
timeFrame: immediately after procedure
measure: Length of stay
timeFrame: From procedure to discharge, estimated average = 36 hours
measure: Blood transfusions
timeFrame: From procedure to discharge, estimated average = 36 hours
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Danville
country: United States
facility: Spectrum Medical Inc
state: Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Schwab, MD
role: PRINCIPAL_INVESTIGATOR
References: