NOBLE-Open: Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
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 open gynecological, urological, ENT and head and neck, and vascular surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uniklinikum | Salzburg | Austria | ||
| 2 | Centre Hospitalier Universitaire d'Angers | Angers | France | ||
| 3 | CHU Grenoble | Grenoble | France | ||
| 4 | Hopital Saint-Joseph | Paris | France | 75014 | |
| 5 | Clinique Rive Gauche | Toulouse | France | 31300 | |
| 6 | Universitatsklinikum Bonn | Bonn | Germany | 53127 | |
| 7 | Agaplesion Markus krankenhaus | Frankfurt | Germany | 60487 | |
| 8 | Kliniken der Stadt Koln, Krankenhaus Merheim | Köln | Germany | 51067 | |
| 9 | St Franzikus-Hospital | Münster | Germany | 48145 |
Sponsors and Collaborators
- Biom'Up France SAS
Investigators
- Principal Investigator: Tim Vilz, MD, Unversity Hospital Bonn
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ETC 2018-001