Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Study Details
Study Description
Brief Summary
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.
Study Design
Outcome Measures
Primary Outcome Measures
- Achievement of Hemostasis [Intraoperatively, expected within 3-10 minutes of application]
The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.
Secondary Outcome Measures
- Incidence of Serious Adverse Device Effects (SADEs) [4 weeks +/- 2 weeks]
The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows
- Re-bleeding at Target Bleeding Site [Intraoperative, prior to surgical closure of the subject]
The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows
- Re-operation due to bleeding [Post-operatively, expected within 1-28 days of the surgical procedure]
The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
Eligibility Criteria
Criteria
Pre-operative Inclusion Criteria:
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Patient is undergoing a non-emergent spine surgery
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Patient is willing and able to give prior written informed consent for investigation participation;
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Patient is 18 years of age or older.
Intra-operative Inclusion Criteria
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Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
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The TBS(s) has been treated with HEMOBLAST™ Bellows per instructions for use.
Exclusion Criteria:
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Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
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Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
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Patient has religious or other objections to porcine, bovine, or human components;
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Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
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Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | L'Hôpital privé du Confluent | Nantes | France |
Sponsors and Collaborators
- Biom'Up France SAS
Investigators
- Principal Investigator: Pierre-Marie Longis, MD, L'Hôpital privé du Confluent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ETC 2018-004