Surgical BleedingNCT04734535
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
A study testing HEMOBLAST™ Bellows and absorbable gelatin sponge with thrombin in people with Surgical Bleeding, run by Dilon Technologies Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Surgical Bleeding
- What is being tested?
- HEMOBLAST™ Bellows and absorbable gelatin sponge with thrombin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Mar 2021to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
Indiana Spine Group
Carmel, Indiana, 13225
Spectrum Medical Inc
Danville, Virginia, 24511
University of Southern California
Los Angeles, California, 900033
About this study
Official title: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
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.
- Conditions
- Surgical Bleeding
- Being tested
- HEMOBLAST™ Bellows, absorbable gelatin sponge with thrombin
- Keywords
- Elective, spine surgery, bleeding control, hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOBLAST™ BellowsDevice
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
absorbable gelatin sponge with thrombinDevice
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin
| Study group | Role | What they receive |
|---|---|---|
| investigational | Experimental | HEMOBLAST™ Bellows Receives: Device: HEMOBLAST™ Bellows |
| control | Active comparator | absorbable gelatin sponge with thrombin Receives: Device: absorbable gelatin sponge with thrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Unanticipated Adverse Device Effect (UADE)
incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).
Measured: 3 months follow-up
Secondary outcomes (1)
Adverse events (AE)
the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start8 Mar 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilon Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Joseph Schwab, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734535
- Sponsor's protocol ID
- ETC-2020-001
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
- ClinicalTrials.gov ID
- NCT04734535
- Acronym / sponsor ID
- ETC-2020-001
- Conditions
- Surgical Bleeding
- Keywords
- Elective, spine surgery, bleeding control, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dilon Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
| Arm | Type | Receives |
|---|---|---|
| investigational | Experimental | Device: HEMOBLAST™ BellowsHEMOBLAST™ Bellows |
| control | Active comparator | Device: absorbable gelatin sponge with thrombinabsorbable gelatin sponge with thrombin |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMOBLAST™ BellowsIntraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows | Device | investigational |
| absorbable gelatin sponge with thrombinIntraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin | Device | control |
Primary outcome
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).
1 secondary outcome
Adverse events (AE)
Time frame: 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Schwab, MD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEMOBLAST™ Bellows and absorbable gelatin sponge with thrombin in people with Surgical Bleeding, run by Dilon Technologies Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Unanticipated Adverse Device Effect (UADE) (time frame: 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.