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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEMOBLAST™ Bellows | Device | 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 laparoscopic abdominal, gynecological, or urological surgeries. |
| 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 |
| 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 |
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Pre-operative Inclusion Criteria:
Intra-operative Inclusion Criteria
Exclusion Criteria:
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Subjects undergoing laparoscopic abdominal, gynecological, or urological procedures that meet all of the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Vilz, MD | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Salzburg | Salzburg | Austria | ||||
| Hôpital Beaujon |
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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 |
| Clichy |
| France |
| CHU Grenoble | Grenoble | France |
| Hôpital Saint Jospeh | Paris | 75674 | France |
| University Hospital Bonn | Bonn | Germany |
| Kliniken der Stadt Koln, Krankenhaus Merheim | Cologne | 51109 | Germany |
| Agaplesion Markus Krankenhaus | Frankfurt am Main | 60487 | Germany |
| Asklepios Klinik Barmbek | Hamburg | Germany |