NCT07130708 · AdventHealth
Exploring the Potential of Robotic Telesurgery in Remote Settings
What this study is about
This study involves a type of robotic surgery called telesurgery, where a highly trained surgeon performs the surgical procedure using a secure internet connection to operate on a patient in a different location. Urologists from The goal of this study is to find out how safe and effective telesurgery is when used in real hospitals.
View original scientific description
This study involves a type of robotic surgery called telesurgery, where a highly trained surgeon performs the surgical procedure using a secure internet connection to operate on a patient in a different location. 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 understand how well Telesurgery works in different settings, what technical challenges might come up (like internet speed or delays), and how it can be used to train new surgeons.
Interventions
DEVICE
Telesurgery utilizing Microport Medbot Robotic Platform
A robotic surgery for prostate disease via telesurgery, where a highly trained surgeon performs the operation remotely using a secure internet connection.
Primary outcome measures
Primary Outcome Measures (Endpoints)
Time frame: The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length.
One of the investigator's primary outcome measures is the safety and feasibility of the Microport Medbot Robotic Platform for use in Telesurgery through maintaining a stable connection. The investigator will monitor feasibility through perioperative connectivity assessment provided by the platform. Outcome of Latency- Medbot platform measures in milliseconds. This is monitored by the investigator. Measured in Milliseconds per round trip time (ms/RTT). The acceptable threshold is under 200ms. Robotic Platform Performance Logs- The robotic system itself continuously logs and reports performance metrics, including latency. Dedicated Tech team: Oversees and monitors connection status throughout procedure.
Secondary Endpoints
Time frame: This will be measured by the investigator from the start of the surgical procedure through the completion of the surgical procedure.
Investigators assessment of and response to perioperative complications (complications observed will be classified using the Clavien-Dindo Classification with Grades I thru V).
Safety and Feasibility: Maintenance of stable connection
Time frame: The measured time frame for this outcome will be measured by the investigator and tech team from the start of the surgical procedure through the stop time of the surgical procedure. Approximately 90 minutes in length.
One of the investigator's primary outcome measures is the safety and feasibility of the Microport Medbot Robotic Platform for use in Telesurgery through maintaining a stable connection. The investigator will monitor feasibility through perioperative connectivity Outcome: Bandwidth and Network Stability- The surgical team monitors bandwidth to ensure a consistent, high-speed internet connection. Bandwidth measured in megabits per second (Mbps). The goal of 100Mbps is recommended. Measurement is made through tracking on data transmission rates reported by the robotic system itself which continuously logs and reports data in real time. Dedicated Tech Team: Oversees and monitors connection status throughout the procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 - 90
- Male or female
- Eligible participants for this telesurgery study must have a clearly defined indication for robotic urologic surgery, specifically:
- Localized Prostate Cancer (ICD-10: C61), appropriate for robotic radical prostatectomy. OR -Benign Prostate diseases appropriate for robotic simple prostatectomy (ICD-10: N40) These diagnoses are confirmed by clinical examination, imaging, and/or pathology prior to surgical planning. Patients with vague or unspecified urologic conditions will be excluded to ensure the safety and appropriateness of the surgical intervention.
- Primary diagnosis of urinary system disease and prostate disorders (C61 and N40.1) scheduled to undergo treatment with robotic surgery. These patients don't have access to robotic surgery in their routine and the study will give them the opportunity to have advanced technology and the gold-standard treatment with experts in the field.
- Willing to participate in the study
- Mentally capable of comprehending the study protocol
Exclusion criteria
- Patients who, based on multidisciplinary evaluation (surgical, anesthetic, and medical), are deemed not suitable for robotic surgery due to high perioperative risk. This includes but is not limited to:
- Uncontrolled cardiovascular, pulmonary, or metabolic disease.
- 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)
- Cognitively impaired or decisional incapacitated individuals
Where
- Celebration, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations