Hemostasis
Conditions
Brief summary
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
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.
Interventions
DEVICEHEMOBLAST™ Bellows
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 spine surgery.
Sponsors
Biom'Up France SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-operative Inclusion Criteria: * Patient is undergoing a non-emergent spine surgery * Patient is willing and able to give prior written informed consent for investigation participation; * Patient is 18 years of age or older. Intra-operative Inclusion Criteria * Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical. * The TBS(s) has been treated with HEMOBLAST™ Bellows per instructions for use.
Exclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed