Clinical trial · Interventional
Clinical Investigation of the da Vinci Surgical System
A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
NCT05682742CI-TRIAL-00077677active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Disease | — | UNRESOLVED | — |
| Inguinal Hernia | — | UNRESOLVED | — |
| Mediastinal Tumor | Mediastinal Neoplasm | ALIAS | 0.90 |
| Obesity, Morbid | — | UNRESOLVED | — |
| Pelvic Organ Prolapse | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Disease | — | UNRESOLVED | — |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
| Ventral Hernia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic-assisted Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic-assisted surgery
- description
- Subjects scheduled to undergo robotic-assisted surgery
- interventionNames
- Device: Robotic-assisted Surgery
Primary outcomes (1)
- measure
- Incidence of conversion
- timeFrame
- Intra-operative
- description
- Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
Secondary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- 30-day follow-up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Pre-operative Inclusion Criteria: * Age 21 years or older * Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure Pre-operative Exclusion Criteria: * Subject is pregnant or suspected to be pregnant or breastfeeding * Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data * Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months * Subject belongs to vulnerable population. * Subject is contraindicated for anesthesia or surgery * Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months
References
Publications (1)
- DERIVEDMerritt 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. PMID 41032176