Robotic Telesurgery for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Cardiovascular, Pulmonary, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical method for prostate cancer using the Microport Medbot Robotic Platform, a robotic technology operated over the internet. The trial aims to assess the safety and effectiveness of this remote surgery in real hospital settings and identify potential challenges, such as internet connectivity issues. Additionally, it examines how this technology can aid in training new surgeons. Men with localized prostate cancer or certain non-cancerous prostate conditions who require surgery and lack access to robotic surgery may be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could transform surgical training and access.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this robotic telesurgery technique is safe for prostate cancer patients?

A previous study used the Microport Medbot Robotic Platform in six successful robotic surgeries for prostate cancer. These surgeries demonstrated the system's safe and effective use. Research has indicated that this robotic platform is designed to be well-tolerated by patients, with no major safety concerns reported. The study specifically examined the safety and practicality of using this platform for telesurgery, where a surgeon operates from a different location. No significant adverse events occurred during these procedures, suggesting a good safety profile for this type of surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic telesurgery for prostate cancer because it has the potential to revolutionize how surgeries are performed, especially in remote areas. Unlike traditional surgery that requires the surgeon to be physically present, this approach uses the Microport Medbot Robotic Platform to allow surgeons to perform operations from a distance. This could greatly increase access to high-quality surgical care for patients living in rural or underserved communities. Additionally, robotic telesurgery may offer more precision and less room for human error, which can lead to better outcomes and faster recovery times for patients.

What evidence suggests that robotic telesurgery is effective for prostate cancer?

This trial will explore the potential of robotic telesurgery for prostate cancer using the Microport Medbot Robotic Platform. Research has shown that robotic telesurgery, such as that performed with this platform, can successfully conduct complex surgeries from a distance. In past cases, this system performed robot-assisted prostate surgery, proving its effectiveness. One study highlighted that remote surgery can enhance surgical skills and patient outcomes by enabling expert surgeons to operate from afar. Additionally, robotic surgery has proven to be safe and practical, even when conducted remotely. These findings suggest that robotic telesurgery could be a promising option for treating prostate cancer, particularly in areas with limited access to specialized surgeons. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-90 with prostate cancer or benign prostate diseases appropriate for robotic surgery. Candidates must be mentally capable of understanding the study, not at high perioperative risk, and not involved in other conflicting studies.

Inclusion Criteria

I am either male or female.

I am between 18 and 90 years old.

I have prostate cancer or benign prostate disease and am fit for robotic surgery.

Exclusion Criteria

Patients who, based on multidisciplinary evaluation, are deemed not suitable for robotic surgery due to high perioperative risk including uncontrolled cardiovascular, pulmonary, or metabolic disease, and severe anesthetic risk classified as ASA Class IV or higher. Patients enrolled in another interventional research study that may interfere with surgical safety or outcomes. Patients unwilling or unable to comply with the perioperative and follow-up schedule. Vulnerable populations are excluded from this study, including minors (under 18 years old), prisoners, cognitively impaired or decisional incapacitated individuals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telesurgery Procedure

Participants undergo telesurgery using the Microport Medbot Robotic Platform, monitored for safety and feasibility

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the telesurgery procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microport Medbot Robotic Platform

Trial Overview The study tests telesurgery using the Microport Medbot Robotic Platform for urologic procedures. It aims to assess safety, effectiveness, technical challenges like internet issues, and its potential as a training tool for new surgeons.

How Is the Trial Designed?

Group I: Exploring the Potential of Robotic Telesurgery in Remote Settings Experimental Treatment 1 Intervention

Telesurgery

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Citations

1. microport.com microport.com/news/microport-medbot-s-toumai-surgical-robot-system-completes-multiple-landmark-robotic-telesurgery-cases-in-sub-sahara-africa-in-the-republic-of-angola

MicroPort® MedBot™'s Toumai® Surgical Robot System ... MicroPort® MedBot™ (HKSE:2252) announced today that the company successfully completed 6 robot-assisted laparoscopic radical prostatectomy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07130708

Exploring the Potential of Robotic Telesurgery in Remote ... One of the investigator's primary outcome measures is the safety and feasibility of the Microport Medbot Robotic Platform for use in Telesurgery ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150305/

Insights from telesurgery expert conference on recent ... Remote surgery provides opportunity for enhanced surgical capabilities, wider healthcare reach, and potentially improved patient outcomes.

4. microport.com microport.com/news/microport-medbot-s-toumai-completes-worlds-first-fda-ide-approved-usa-africa-robotic-telesurgery

MicroPort® MedBot™'s Toumai® Completes World's First ... On June 14, Professor Vipul Patel, President of the Society of Robotic Surgery (SRS), remotely performed a successful radical prostatectomy ...

5. withpower.com withpower.com/trial/phase-prostatic-diseases-5-2025-222dd

Robotic Telesurgery for Prostate Cancer Trial Overview The study tests telesurgery using the Microport Medbot Robotic Platform for urologic procedures. It aims to assess safety, effectiveness ...

6. patlynk.com patlynk.com/trial/NCT07130708

Robotic Telesurgery in Remote Healthcare Settings This study is exploring the use of robotic telesurgery, which is a type of surgery performed by a specialized surgeon from a distance using ...

7. smartpatients.com smartpatients.com/trials/NCT07130708

Exploring the Potential of Robotic Telesurgery in Remote ... Urologists from The goal of this study is to find out how safe and effective telesurgery is when used in real hospitals. The study aims to ...