Prostate CancerNCT07541066
Robotic Telesurgery in Urology
A study testing High-Intensity Focused Ultrasound (HIFU) robotic device in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-Intensity Focused Ultrasound (HIFU) robotic device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Glickman Urological Institute
Cleveland, Ohio, 44195
About this study
Official title: Robotic Telesurgery for Prostate Cancer
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- High-Intensity Focused Ultrasound (HIFU) robotic device
- Keywords
- High-Intensity Focused Ultrasound (HIFU), Telesurgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Focused Ultrasound (HIFU) robotic deviceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic telesurgery | Experimental | Not described Receives: Procedure: High-Intensity Focused Ultrasound (HIFU) robotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (up to 90 days)
Secondary outcomes (14)
Total operative time (minutes)
Total operative time will be measured in minutes on the day of surgery.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (up to 90 days)
Intraoperative complications
Intraoperative complications will be measured as the number of instances of complications.
Measured: 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.
Measured: 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.
Measured: Day 1 (up to 90 days)
Postoperative hospital length of stay (hours)
Postoperative hospital length of stay will be measured in hours.
Measured: Up to Day 90
Postoperative complications
Postoperative complications will be measured as the number of instances of complications.
Measured: Up to Day 90
Hospital readmission within 90 days of surgery
Hospital readmissions will be measured as number of instances of readmissions.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Focal One, INC
- Responsible party
- Sponsor
- Investigators
- Ruben Olivares, MD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541066
- Sponsor's protocol ID
- CASE11825
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19638912Marescaux 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.
PubMed 11574874Moschovas 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.
PubMed 39226445Olivares 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.
PubMed 40891484Novara 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.
PubMed 22749853
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Telesurgery for Prostate Cancer
- ClinicalTrials.gov ID
- NCT07541066
- Acronym / sponsor ID
- CASE11825
- Conditions
- Prostate Cancer
- Keywords
- High-Intensity Focused Ultrasound (HIFU), Telesurgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Focal One, INC
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic telesurgery | Experimental | Procedure: High-Intensity Focused Ultrasound (HIFU) robotic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Focused Ultrasound (HIFU) robotic deviceParticipants 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. | Procedure or surgery | Robotic telesurgery |
Primary outcome
Surgical success rate
Time frame: Day 1 (up to 90 days)
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.
14 secondary outcomes
Total operative time (minutes)
Time frame: Day 1 (up to 90 days)
Total robotic console time (minutes)
Time frame: Day 1 (up to 90 days)
Distance between the two institutions (miles)
Time frame: Day 1 (up to 90 days)
Round-trip latency time (milliseconds)
Time frame: Day 1 (up to 90 days)
Intraoperative blood loss (milliliters (mL))
Time frame: Day 1 (up to 90 days)
Conversion from remote to in-house surgeon
Time frame: Day 1 (up to 90 days)
Conversion from planned surgery to other techniques
Time frame: Day 1 (up to 90 days)
Conversion from one robotic surgical system to another
Time frame: Day 1 (up to 90 days)
Intraoperative complications
Time frame: Day 1 (up to 90 days)
Evidence of intraoperative network interruptions
Time frame: Day 1 (up to 90 days)
Evidence of intraoperative device malfunctions
Time frame: Day 1 (up to 90 days)
Postoperative hospital length of stay (hours)
Time frame: Up to Day 90
Postoperative complications
Time frame: Up to Day 90
Hospital readmission within 90 days of surgery
Time frame: Up to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 19638912Clavien 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.
- Background: PubMed 11574874Marescaux 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.
- Background: PubMed 39226445Moschovas 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.
- Background: PubMed 40891484Olivares 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.
- Background: PubMed 22749853Novara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Olivares, MD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Focused Ultrasound (HIFU) robotic device in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: Day 1 (up to 90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541066, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.