Robotic Telesurgery in Urology

NCT07541066 | Withdrawn DMC

• 1 other identifier: CASE11825
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

High-Intensity Focused Ultrasound (HIFU); Telesurgery

Outcome Measures

Primary Outcomes (1)

• Surgical success rate

  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.

  Day 1 (up to 90 days)

Secondary Outcomes (14)

• Total operative time (minutes)

  Day 1 (up to 90 days)

• Total robotic console time (minutes)

  Day 1 (up to 90 days)

• Distance between the two institutions (miles)

  Day 1 (up to 90 days)

• Round-trip latency time (milliseconds)

  Day 1 (up to 90 days)

• Intraoperative blood loss (milliliters (mL))

  Day 1 (up to 90 days)

Study Arms (1)

Robotic telesurgery

EXPERIMENTAL

Procedure: High-Intensity Focused Ultrasound (HIFU) robotic device

Interventions

High-Intensity Focused Ultrasound (HIFU) robotic device PROCEDURE

Participants will receive surgery using the High-Intensity Focused Ultrasound (HIFU) robotic device, using the existing, secured network as part of the Cleveland Clinic infrastructure, to deliver focal ablative treatment for prostate cancer.

Robotic telesurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Focal One, INC: collaborator

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Glickman Urological Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

• Clavien 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 BACKGROUND

• Marescaux, J., Leroy, J., Gagner, M., Rubino, F., Mutter, D., & Vix, M. (2001). Transatlantic robot-assisted telesurgery. Nature, 413(6854), 379-380.

  BACKGROUND

• Moschovas, M. C., Rogers, T., Xu, W., Perera, R., Zhang, X., & Patel, V. (2024). First impressions of telesurgery robotic-assisted radical prostatectomy using the Edge medical robotic platform. International Brazilian Journal of Urology, 50(6), 754-763.

  BACKGROUND

• Olivares R, Kaouk J, Soputro NA, Weight CJ, Haber GP, Hassen 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

  BACKGROUND

• Novara, G., Ficarra, V., Rosen, R. C., Artibani, W., Costello, A., Eastham, J. A., ... & Wilson, T. G. (2012). Systematic review and meta-analysis of perioperative outcomes and complications after robot-assisted radical prostatectomy. European urology, 62(3), 431-452.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ruben Olivares, MD

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)