Not provided
Not provided
Not provided
Not provided
Not provided
PI left institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Focal One, INC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Robotic surgery began in the early 2000s and has been increasingly considered the preferred surgical approach for various urological surgeries. Urologists were among the first doctors to adopt this technology, and today, robotic surgery is included in many medical guidelines as a main treatment option for localized urological cancers. As robotic systems become more widely available and continue to improve, many new treatment options have been developed in the field of urologic cancer care. These advances offer the benefit of less invasive surgery. However, having more complex surgical options can also create challenges. Access to highly trained surgeons and specialized treatments may be limited to large academic or major medical centers, making it harder for some people to receive this care.
Telesurgery has been introduced as a way to make the process of robotic surgical care more accessible. Telesurgery is defined as the completion of a robotic surgical procedure by a remote surgeon that is located distant to the person receiving surgery. Although telesurgery was first described by researchers in 2001, the widespread adoption of telesurgery is limited by the availability of surgical technology, reliable and secure high-speed network infrastructure, and regulatory constraints.
In addition to the robotic console and participant cart required for the standard robotic procedures, telesurgery also requires an additional robotic console for the remote surgeon that mimics the functionality of the primary console. In addition, separate network tests using phantom models constituted mandatory preparation prior to the actual procedure to ensure a reliable, low-latency network infrastructure.
Preliminary studies have reported on the safety of robotic telesurgery. Most of these studies involve using telesurgery for the management of localized prostate cancer. However, these studies are limited by small sample sizes, heterogeneous study design, robotic surgical platform, and clinical practices. Furthermore, there remains a lack of consensus on best practice guidelines on robotic telesurgery, particularly involving the network requirements, ethical considerations, and intraoperative requirements.
This study aims to confirm the safety and feasibility of robotic telesurgery when used for the surgical management of prostate cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic telesurgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time (minutes) | Total operative time will be measured in minutes on the day of surgery. | Day 1 (up to 90 days) |
| Total robotic console time (minutes) | Total robotic console time is the amount of time that the robotic console is in use during surgery and will be measured in minutes on the day of surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ruben Olivares, MD | Case Comprehensive Cancer Center, Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center, Cleveland Clinic Foundation Glickman Urological Institute | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638912 | Background | 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. | |
| 11574874 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 (up to 90 days) |
| Distance between the two institutions (miles) | The distance between two institutions refers to the distance between the surgeon console operated by the remote surgeon and the robotic patient cart where the patient is located. If these are at two different institutions, distance between institutions will be measured in miles. | Day 1 (up to 90 days) |
| Round-trip latency time (milliseconds) | Round-trip latency time is defined as the total time delay between an action initiation on the robotic console and that corresponding action being carried out. Round-trip latency time is measured in milliseconds (ms). | Day 1 (up to 90 days) |
| Intraoperative blood loss (milliliters (mL)) | Intraoperative blood loss will be measured in milliliters (mL) on the day of surgery. | Day 1 (up to 90 days) |
| Conversion from remote to in-house surgeon | Conversion from remote to in-house surgeon occurs when the network latency exceeds 300 milliseconds (ms). This will be measured as number of instances of conversion. | Day 1 (up to 90 days) |
| Conversion from planned surgery to other techniques | Conversion will be measured as number of instances of conversion from planned surgery to other techniques, at the discretion of the surgeon. | Day 1 (up to 90 days) |
| Conversion from one robotic surgical system to another | Conversion will be measured as number of instances of conversion from the planned robotic surgical system to other backup surgical systems, at the discretion of the surgeon. | Day 1 (up to 90 days) |
| Intraoperative complications | Intraoperative complications will be measured as the number of instances of complications. | Day 1 (up to 90 days) |
| Evidence of intraoperative network interruptions | Intraoperative network interruptions include those pertaining to the robotic procedure, including interruptions to the audiovisual feed, and this will be measured as number of instances of interruptions. | Day 1 (up to 90 days) |
| Evidence of intraoperative device malfunctions | This will be measured as the number of instances of device malfunctions during surgery. | Day 1 (up to 90 days) |
| Postoperative hospital length of stay (hours) | Postoperative hospital length of stay will be measured in hours. | Up to Day 90 |
| Postoperative complications | Postoperative complications will be measured as the number of instances of complications. | Up to Day 90 |
| Hospital readmission within 90 days of surgery | Hospital readmissions will be measured as number of instances of readmissions. | Up to Day 90 |
| Marescaux 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. |
| 39226445 | Background | Moschovas 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. |
| 40891484 | Background | Olivares 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. |
| 22749853 | Background | Novara 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |