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A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
Primary Effectiveness Endpoint:
• Ability to complete procedure without a need for conversion to a non-robotic approach
Safety Endpoint:
Assessment of adverse events through post-operative follow-up including but not limited to:
• Bleeding
â–ª Mortality
Additional endpoints evaluated may include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic arm | Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic surgery using the da Vinci Surgical System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Ability to complete procedure without a need for conversion to a non-robotic approach | intra-operative |
| Primary Safety endpoint | Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality | up to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
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| Name | Affiliation | Role |
|---|---|---|
| Shilpa Mehendale, MS | Intutive Surgical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middlesex Hospital | Middletown | Connecticut | 06457 | United States | ||
| St. Jose Mercey Health System |
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| Ypsilanti |
| Michigan |
| 48197 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |