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 : January 9, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Surgical Bleeding | Device: HEMOBLAST™ Bellows Device: absorbable gelatin sponge with thrombin | Not Applicable |
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 : | April 2023 |
Estimated Study Completion Date : | April 2023 |
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 |
- 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).
- 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.
- 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
- Operative time [ Time Frame: immediately after procedure ]Operative time for HEMOBLAST™ subjects compared to G+T subjects
- Length of stay [ Time Frame: From procedure to discharge, estimated average = 36 hours ]Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects
- 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 |
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

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
Contact: Maya Livnat | 972.4.617.8000 ext 203 | mlivnat@dilon.com | |
Contact: Kevin Bielski | +1 877 GO DILON | kbielski@dilon.com |
United States, California | |
University of Southern California | 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 | Withdrawn |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Study Coordinator | |
United States, Virginia | |
Spectrum Medical Inc | Completed |
Danville, Virginia, United States, 24511 |
Principal Investigator: | Joseph Schwab, MD | Massachusetts General Hospital |
Responsible Party: | Dilon Technologies Inc. |
ClinicalTrials.gov Identifier: | NCT04734535 |
Other Study ID Numbers: |
ETC-2020-001 |
First Posted: | February 2, 2021 Key Record Dates |
Last Update Posted: | January 9, 2023 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Elective, spine surgery, bleeding control, hemostasis |
Hemorrhage Pathologic Processes Thrombin |
Gelatin Sponge, Absorbable Hemostatics Coagulants |