HemostasisPhase 1NCT02502019
HEMOBLAST Pilot Clinical Investigation
A Phase 1 study testing HEMOBLAST Bellows in people with Hemostasis, run by Biom'Up France SAS at 3 sites in United States.
Trial summary
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemostasis
- What is being tested?
- HEMOBLAST Bellows
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery;
- Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
- Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and
- Subject is 21 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 achieving hemostasis are ineffective or impractical; and
- Subject has a TBS with an SBSS score of 1, 2, or 3.
Who cannot join
- • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
- Subject is undergoing a spinal surgical procedure;
- Subject is undergoing a neurologic surgical procedure;
- Subject is undergoing an emergency surgical procedure;
- Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter and/or International Normalized Ratio > 1.5 within 4 weeks of surgery;
Show all 19Show fewer
- Subject had chronic corticosteroid use within 2 weeks prior to surgery;
- Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery;
- Subject has an active or suspected infection at the surgical site;
- Subject has had or has planned 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 ASA classification of > 4;
- Subject has a life expectancy of less than 3 months;
- Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
- Subject has a documented severe congenital or acquired immunodeficiency;
- Subject has religious or other objections to porcine or bovine components;
- Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant;
- 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
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Danville Orthopedic Clinic
Danville, Virginia
University of Southern California
Los Angeles, California
About this study
Official title: Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
Read the detailed description
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites.
The subjects will be followed at hospital charge and 6 weeks postoperatively.
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Secondary endpoints of this clinical investigation consist of:
- Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application;
- Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application;
- Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and
- Incidence of adverse events through final follow-up.
- Conditions
- Hemostasis
- Being tested
- HEMOBLAST Bellows
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOBLAST BellowsDevice
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
| Study group | Role | What they receive |
|---|---|---|
| HEMOBLAST | Experimental | All subjects will have the investigational device implanted Receives: Device: HEMOBLAST Bellows |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Measured: Intraoperative
Secondary outcomes (4)
Hemostatic Within 6 Minutes
Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application
Measured: Intraoperative
Hemostasis Within 10 Minutes
Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application
Measured: Intraoperative
Hemostasis Within 3 Minutes
Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application
Measured: Intraoperative
Adverse Events
Incidence of adverse events through final follow-up
Measured: 6 +/- 2 weeks after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemostasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biom'Up France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Sher, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502019
- Sponsor's protocol ID
- ETC 2015-001
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2015
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries
- ClinicalTrials.gov ID
- NCT02502019
- Acronym / sponsor ID
- ETC 2015-001
- Conditions
- Hemostasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Biom'Up France SASIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
Detailed description
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites.
The subjects will be followed at hospital charge and 6 weeks postoperatively.
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Secondary endpoints of this clinical investigation consist of:
- Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application;
- Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application;
- Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and
- Incidence of adverse events through final follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMOBLAST | Experimental | Device: HEMOBLAST BellowsAll subjects will have the investigational device implanted |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery;
Key exclusion criteria (19 listed)
- • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
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 BellowsHEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical. | Device | HEMOBLAST |
Primary outcome
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
Time frame: Intraoperative
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
4 secondary outcomes
Hemostatic Within 6 Minutes
Time frame: Intraoperative
Hemostasis Within 10 Minutes
Time frame: Intraoperative
Hemostasis Within 3 Minutes
Time frame: Intraoperative
Adverse Events
Time frame: 6 +/- 2 weeks after implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Linda Sher, MD principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEMOBLAST Bellows in people with Hemostasis, run by Biom'Up France SAS at 3 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 7 inclusion and 19 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators (time frame: Intraoperative). 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 15 Feb 2019.