Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries

Conditions
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Hemostasis

Intervention / Treatment
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* Device: HEMOBLAST™ Bellows


Participation Criteria
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Eligibility Criteria
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Pre-operative Inclusion Criteria: Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular 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 HEMOBLASTTM Bellows as per their 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HEMOBLAST™ 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 gynecological, urological, vascular, ENT and head and neck surgeries.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Hemostasis | The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows. | Intraoperatively, expected within 3-10 minutes of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-bleeding at Target Bleeding Site | The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows | 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 | Post-operatively, expected within 1-30 days of the surgical procedure |