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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 and laparoscopic hysterectomy with adnexal surgery for benign disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysterectomy with adnexal surgery | Procedure | Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease. |
| Measure | Description | Time Frame |
|---|---|---|
| primary safety endpoint | occurrence of Clavien - Dindo grades III-V adverse events | up to 42 days |
| primary performance endpoint | 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 hysterectomy with adnexal surgery for benign disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Saintes - Saint-Jean-d'Angély | Saintes | 17100 | France | |||
| Kantonsspital Baden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40999110 | Derived | Gulz M, Bodet ML, Streich M, Habegger A, Heubner M, Erhardt D, Bogdanovic B, Mueller MD. Multicenter evaluation of the DEXTER(R) Robotic Surgery System for Total Hysterectomy with Adnexal Surgery. J Robot Surg. 2025 Sep 26;19(1):634. doi: 10.1007/s11701-025-02647-0. |
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| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Baden |
| Switzerland |
| Inselspital Bern | Bern | Switzerland |
| Spitäler FMI AG | Interlaken | Switzerland |