HemostasisNOBLE-OpenNCT03873168
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
An observational study of Hemostasis, run by Biom'Up France SAS at 9 sites in 3 countries.
Trial summary
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis
- What is being tested?
- HEMOBLAST™ Bellows
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 9 May 2019to 27 Jul 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing open gynecological, urological, ENT and head and neck, and vascular procedures that meet all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
None listed.
Who cannot join
- Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- Patient has religious or other objections to porcine, bovine, or human components;
- Patient has any significant coagulation disorder;
- Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
- Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France4 sites
Centre Hospitalier Universitaire d'Angers
Angers
CHU Grenoble
Grenoble
Hopital Saint-Joseph
Paris, 75014
Clinique Rive Gauche
Toulouse, 31300
Germany4 sites
Universitatsklinikum Bonn
Bonn, 53127
Kliniken der Stadt Koln, Krankenhaus Merheim
Cologne, 51067
Agaplesion Markus krankenhaus
Frankfurt, 60487
St Franzikus-Hospital
Münster, 48145
About this study
Official title: Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
Read the detailed description
A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.
- 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
Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in gynecological, urological, vascular, ENT and head and neck surgeries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Hemostasis
The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.
Measured: Intraoperatively, expected within 3-10 minutes of application
Secondary outcomes (2)
Re-bleeding at Target Bleeding Site
The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows
Measured: Intraoperative, prior to surgical closure of the subject
Re-operation due to bleeding
The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
Measured: Post-operatively, expected within 1-30 days of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start9 May 2019
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Why it stopped: Indication withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biom'Up France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Vilz, MD, Principal investigator, Unversity Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873168
- Sponsor's protocol ID
- ETC 2018-001
- Acronym
- NOBLE-Open
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries
- ClinicalTrials.gov ID
- NCT03873168
- Acronym / sponsor ID
- NOBLE-Open / ETC 2018-001
- Conditions
- Hemostasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Indication withdrawn
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Biom'Up France SASIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 13 Mar 2019 (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.
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
Detailed description
A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing open gynecological, urological, ENT and head and neck, and vascular procedures that meet all of the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- Patient has religious or other objections to porcine, bovine, or human components;
- Patient has any significant coagulation disorder;
- Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
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™ BellowsSurgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in gynecological, urological, vascular, ENT and head and neck surgeries. | Device | – |
Primary outcome
Achievement of Hemostasis
Time frame: Intraoperatively, expected within 3-10 minutes of application
The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.
2 secondary outcomes
Re-bleeding at Target Bleeding Site
Time frame: Intraoperative, prior to surgical closure of the subject
Re-operation due to bleeding
Time frame: Post-operatively, expected within 1-30 days of the surgical procedure
Results and safety
The study was stopped early (reason given: Indication withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tim Vilz, MD principal investigator
Unversity Hospital Bonn
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis, run by Biom'Up France SAS at 9 sites in 3 countries.
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 0 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Austria. 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 was stopped early (reason given: Indication withdrawn). Results are not available in the source record.
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?
Achievement of Hemostasis (time frame: Intraoperatively, expected within 3-10 minutes of application). 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 30 Aug 2021.