Exploring the Potential of Robotic Telesurgery in Remote Settings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorAdventHealth
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 90
Male or female
Localized Prostate Cancer (ICD-10: C61), appropriate for robotic radical prostatectomy.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Telesurgery utilizing Microport Medbot Robotic Platform
DeviceA robotic surgery for prostate disease via telesurgery, where a highly trained surgeon performs the operation remotely using a secure internet connection.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Exploring the Potential of Robotic Telesurgery in Remote SettingsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measures (Endpoints)
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.
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.2
Secondary Endpoints
Investigators assessment of and response to perioperative complications (complications observed will be classified using the Clavien-Dindo Classification with Grades I thru V).
Time frame
This will be measured by the investigator from the start of the surgical procedure through the completion of the surgical procedure.3
Safety and Feasibility: Maintenance of stable connection
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov