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Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Primary Purpose

Surgical Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEMOBLAST™ Bellows
absorbable gelatin sponge with thrombin
Sponsored by
Dilon Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Bleeding focused on measuring Elective, spine surgery, bleeding control, hemostasis

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • Indiana Spine GroupRecruiting
  • Norton Leatherman Spine Center
  • Massachusetts General HospitalRecruiting
  • Spectrum Medical Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

investigational

control

Arm Description

HEMOBLAST™ Bellows

absorbable gelatin sponge with thrombin

Outcomes

Primary Outcome Measures

Incidence of Unanticipated Adverse Device Effect (UADE)
incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).

Secondary Outcome Measures

Adverse events (AE)
the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.

Full Information

First Posted
January 20, 2021
Last Updated
September 10, 2023
Sponsor
Dilon Technologies Inc.
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT04734535
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dilon Technologies Inc.
Collaborators
Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Bleeding
Keywords
Elective, spine surgery, bleeding control, hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
Masking
Outcomes Assessor
Masking Description
data blinding to Sponsor, Independent Data Monitoring Committee, FDA reviewer
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
investigational
Arm Type
Experimental
Arm Description
HEMOBLAST™ Bellows
Arm Title
control
Arm Type
Active Comparator
Arm Description
absorbable gelatin sponge with thrombin
Intervention Type
Device
Intervention Name(s)
HEMOBLAST™ Bellows
Intervention Description
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
Intervention Type
Device
Intervention Name(s)
absorbable gelatin sponge with thrombin
Intervention Description
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin
Primary Outcome Measure Information:
Title
Incidence of Unanticipated Adverse Device Effect (UADE)
Description
incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Adverse events (AE)
Description
the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.
Time Frame
3 months follow-up
Other Pre-specified Outcome Measures:
Title
Hemostasis within 6 minutes
Description
Proportion of subjects achieving hemostasis within 6 minutes for HEMOBLAST™ subjects compared to G+T subjects
Time Frame
immediately after procedure
Title
Operative time
Description
Operative time for HEMOBLAST™ subjects compared to G+T subjects
Time Frame
immediately after procedure
Title
Length of stay
Description
Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects
Time Frame
From procedure to discharge, estimated average = 36 hours
Title
Blood transfusions
Description
Number of units of blood transfused intraoperatively for HEMOBLAST™ subjects compared to G+T subjects
Time Frame
From procedure to discharge, estimated average = 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Livnat
Phone
972.4.617.8000
Ext
203
Email
mlivnat@dilon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Bielski
Phone
+1 877 GO DILON
Email
kbielski@dilon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Schwab, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
900033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Specialist
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
13225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Team Lead
First Name & Middle Initial & Last Name & Degree
Kenneth Renkens, MD
Facility Name
Norton Leatherman Spine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Spectrum Medical Inc
City
Danville
State/Province
Virginia
ZIP/Postal Code
24511
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

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