NOBLE-Laparo: Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Study Details
Study Description
Brief Summary
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 laparoscopic abdominal, gynecological, and urological surgery. Up to 100 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.
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
- 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 1-30 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 laparoscopic abdominal, gynecological, or urological 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 and the HEMOBLAST™ Bellows Laparoscopic Applicator as per their 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 significant coagulation disorder;
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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 | University Hospital Salzburg | Salzburg | Austria | ||
| 2 | Hôpital Beaujon | Clichy | France | ||
| 3 | CHU Grenoble | Grenoble | France | ||
| 4 | Hôpital Saint Jospeh | Paris | France | 75674 | |
| 5 | University Hospital Bonn | Bonn | Germany | ||
| 6 | Agaplesion Markus Krankenhaus | Frankfurt am main | Germany | 60487 | |
| 7 | Asklepios Klinik Barmbek | Hamburg | Germany | ||
| 8 | Kliniken der Stadt Koln, Krankenhaus Merheim | Köln | Germany | 51109 |
Sponsors and Collaborators
- Biom'Up France SAS
Investigators
- Principal Investigator: Tim Vilz, MD, University Hospital, Bonn
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ETC 2018-002