Clinical trial · Interventional
Prospective Investigation of Robotic Single-port System
NCT02136121CI-TRIAL-00014487completedPhase 1 / Phase 2ClinicalTrials.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)
To determine the feasibility of representative urologic procedures as measured by the rate of conversions
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate and Kidney Cancer | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci Sp Surgical System - Robotic | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- da Vinci Sp Surgical System
- description
- da Vinci Sp Surgical System - Robotic - assisted single-port surgery
- interventionNames
- Device: da Vinci Sp Surgical System - Robotic
Primary outcomes (1)
- measure
- To determine the feasibility as measured by the rate of conversions
- timeFrame
- Intra Operative
- description
- Rate of Conversion to Open approach
Secondary outcomes (5)
- measure
- Perioperative surgical outcomes
- timeFrame
- From admission to discharge from the hospital for the primary procedure typically up to 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Prostatectomy: * Patients age 18-75 years * BMI \<=35 kg/m2 * Confirmed localized adenocarcinoma of the prostate * Suitable for minimally invasive prostate cancer surgery Nephrectomy: * Patient age 18-75 years * BMI \<=35 kg/m2 * Kidney disease amenable to nephrectomy or partial nephrectomy * Suitable for minimally invasive kidney surgery Exclusion Criteria: Untreated active infection (includes local kidney infection) * Vulnerable population (ex: prisoners, mentally disabled) * Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer) * Anatomy unsuitable for endoscopic visualization or minimally invasive surgery * Patient with second primary cancer * Extensive previous abdominal surgery * Prior radiation treatment for prostate or kidney cancer * Patient with distant metastasis * Complex renal vascular anatomy * Patient with kidney cancer - stage T3 or N+ M+ \*\* * Horseshoe kidney\*\* * Previous ipsilateral kidney surgery \*\*- specific to kidney surgery -
References
Publications (1)
- DERIVEDKaouk JH, Haber GP, Autorino R, Crouzet S, Ouzzane A, Flamand V, Villers A. A novel robotic system for single-port urologic surgery: first clinical investigation. Eur Urol. 2014 Dec;66(6):1033-43. doi: 10.1016/j.eururo.2014.06.039. Epub 2014 Jul 17. PMID 25041850