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| Name | Class |
|---|---|
| Confinis | INDUSTRY |
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This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacrocolpopexy or sacrocervicopexy | Device | Robotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety outcome | Occurrence of Clavien-Dindo grades III-V adverse events | up to 42 days after surgery |
| Primary efficacy outcome | Successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing a sacrocolpopexy or sacrocervicopexy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | Germany | ||||
| Universitätsklinikum Bonn |
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| Bonn |
| Germany |
| Krankenhaus St. Elisabeth | Damme | Germany |
| Universitätsmedizin Essen | Essen | Germany |
| Inselspital Bern | Bern | Switzerland |
| Spitäler FMI AG | Interlaken | Switzerland |