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Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

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ClinicalTrials.gov Identifier: NCT04734535
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Biom'Up France SAS

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.

Condition or disease Intervention/treatment Phase
Surgical Bleeding Device: HEMOBLAST™ Bellows Device: absorbable gelatin sponge with thrombin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
Masking: Single (Outcomes Assessor)
Masking Description: data blinding to Sponsor, Independent Data Monitoring Committee, FDA reviewer
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: investigational
HEMOBLAST™ Bellows
Device: HEMOBLAST™ Bellows
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows

Active Comparator: control
absorbable gelatin sponge with thrombin
Device: absorbable gelatin sponge with thrombin
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin




Primary Outcome Measures :
  1. Incidence of Unanticipated Adverse Device Effect (UADE) [ Time Frame: 3 months follow-up ]
    incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).


Secondary Outcome Measures :
  1. Adverse events (AE) [ Time Frame: 3 months follow-up ]
    the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.


Other Outcome Measures:
  1. Hemostasis within 6 minutes [ Time Frame: immediately after procedure ]
    Proportion of subjects achieving hemostasis within 6 minutes for HEMOBLAST™ subjects compared to G+T subjects

  2. Operative time [ Time Frame: immediately after procedure ]
    Operative time for HEMOBLAST™ subjects compared to G+T subjects

  3. Length of stay [ Time Frame: From procedure to discharge, estimated average = 36 hours ]
    Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects

  4. Blood transfusions [ Time Frame: From procedure to discharge, estimated average = 36 hours ]
    Number of units of blood transfused intraoperatively for HEMOBLAST™ subjects compared to G+T subjects



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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; and
  • 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; and
  • 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 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 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; and
  • 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; and
  • The product will be placed in the intradural or cranial space.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734535


Contacts
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Contact: Mindy Ditch +1 (612) 718 9699 M.Ditch@biomup.com
Contact: William Spotnitz, MD w.spotnitz@biomup.com

Locations
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United States, California
University of Southern California Not yet recruiting
Los Angeles, California, United States, 900033
Contact: Project Specialist         
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 13225
Contact: Clinical Team Lead         
Principal Investigator: Kenneth Renkens, MD         
United States, Kentucky
Norton Leatherman Spine Center Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Study Coordinator         
United States, Virginia
Spectrum Medical Inc Recruiting
Danville, Virginia, United States, 24511
Contact: Site Director         
Sponsors and Collaborators
Biom'Up France SAS
Syneos Health
Investigators
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Principal Investigator: Kenneth Renkens, MD Indiana Spine Group
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Responsible Party: Biom'Up France SAS
ClinicalTrials.gov Identifier: NCT04734535    
Other Study ID Numbers: ETC-2020-001
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Biom'Up France SAS:
Elective, spine surgery, bleeding control, hemostasis
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants