Clinical trial · Interventional
Robotic Telesurgery in Urology
Robotic Telesurgery for Prostate Cancer
NCT07541066CI-TRIAL-00108918withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
The goal of this clinical trial is to confirm the safety and feasibility of robotic telesurgery when used for the surgical management of prostate cancer in participates undergoing treatment for prostate cancer. In this clinical trial, participants will receive robotic telesurgery treatment for prostate cancer.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Intensity Focused Ultrasound (HIFU) robotic device | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic telesurgery
- interventionNames
- Procedure: High-Intensity Focused Ultrasound (HIFU) robotic device
Primary outcomes (1)
- measure
- Surgical success rate
- timeFrame
- Day 1 (up to 90 days)
- description
- Surgical success rate is defined as the procedure not requiring any conversion, without any evidence of perioperative complications. Conversion was defined as the switch from the intended surgery to other surgical techniques and/or modalities. Surgical complications of interest included major complications defined as those scoring grades 3a and above according to the Clavien-Dindo classification systems.
Secondary outcomes (14)
- measure
- Total operative time (minutes)
- timeFrame
- Day 1 (up to 90 days)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants, aged 18 years or older * Participant has been indicated for a focal therapy treatment for prostate cancer, radical prostatectomy, or partial nephrectomy robotic procedures * Each participant should fit the clinical criteria to undergo robotic radical procedure, using either the Single Port or Multi Port robotic approaches, laparoscopic, or an open surgical procedure * Each participant should be willing to participate and consent to participate, as documented by a signed informed consent form Exclusion Criteria: * Participants for which minimally invasive surgery is contraindicated as determined by the investigator * Participants with comorbidities or medical characteristics, which would preclude the surgical procedure or the equivalent alternative in the opinion of the investigator * Participants who have been diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard of care * Non-oncology participants with an estimated life expectancy of less than 6 months * Female participants pregnant at the time of the surgical procedure * Participants who are considered to be part of a vulnerable population, including but not limited to those without sufficient mental capacity * Participants who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study * Participants with active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
References
Publications (5)
- BACKGROUNDClavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. PMID 19638912
- BACKGROUNDMarescaux J, Leroy J, Gagner M, Rubino F, Mutter D, Vix M, Butner SE, Smith MK. Transatlantic robot-assisted telesurgery. Nature. 2001 Sep 27;413(6854):379-80. doi: 10.1038/35096636. No abstract available. PMID 11574874
- BACKGROUNDMoschovas MC, Rogers T, Xu W, Perera R, Zhang X, Patel V. First impressions of Telesurgery robotic-assisted radical prostatectomy using the Edge medical robotic platform. Int Braz J Urol. 2024 Nov-Dec;50(6):754-763. doi: 10.1590/S1677-5538.IBJU.2024.0458. PMID 39226445
- BACKGROUNDOlivares R, Kaouk J, Soputro NA, Weight CJ, Haber GP, Hassan W. First-in-human transcontinental telesurgery collaboration for high intensity-focused ultrasound: a new era in globalizing focal treatment for prostate cancer. Minerva Urol Nephrol. 2025 Aug;77(4):561-565. doi: 10.23736/S2724-6051.25.06506-1. PMID 40891484
- BACKGROUNDNovara G, Ficarra V, Rosen RC, Artibani W, Costello A, Eastham JA, Graefen M, Guazzoni G, Shariat SF, Stolzenburg JU, Van Poppel H, Zattoni F, Montorsi F, Mottrie A, Wilson TG. Systematic review and meta-analysis of perioperative outcomes and complications after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):431-52. doi: 10.1016/j.eururo.2012.05.044. Epub 2012 Jun 2. PMID 22749853