Exploring the Potential of Robotic Telesurgery in Remote Settings

Not Applicable

Recruiting

• Conditions: Prostate Carcinoma; Prostate Disease

• Registration Number: NCT07130708
• Lead Sponsor: AdventHealth

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-14
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-08-16
• Last Update Submitted: 2025-08-16
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2028-09-30
• Study Completion: 2033-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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)
  • Prisoners
  • Cognitively impaired or decisional incapacitated individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures (Endpoints)	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	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	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.

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Celebration, Florida, United States