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This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted surgery | Experimental | Subjects scheduled to undergo robotic-assisted surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted Surgery | Device | Subjects scheduled to undergo robotic-assisted surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of conversion | Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open. | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period. | 30-day follow-up |
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Pre-operative Inclusion Criteria:
Pre-operative Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States | ||
| Sparrow Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41032176 | Derived | Merritt RE, Teixeira A, Needleman B, Meara M, Cosgrove C, Sanchez AE, Herrera LJ, Kwasny L, Miller R, Bartley J, Qandeel H, Levy J, Culligan P. A prospective, nonrandomized clinical investigation of the da Vinci surgical system model IS5000. J Robot Surg. 2025 Oct 1;19(1):650. doi: 10.1007/s11701-025-02837-w. |
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| Lansing |
| Michigan |
| 48912 |
| United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| D008479 | Mediastinal Neoplasms |
| D005831 | Genital Diseases, Female |
| D056887 | Pelvic Organ Prolapse |
| D011469 | Prostatic Diseases |
| D011471 | Prostatic Neoplasms |
| D006552 | Hernia, Inguinal |
| D006555 | Hernia, Ventral |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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