Exploring the Potential of Robotic Telesurgery in Remote Settings

August 16, 2025 updated by: Vipul Patel, MD, AdventHealth

Advancing Humanitarian Healthcare: Exploring the Potential of Robotic Telesurgery in Remote Settings - A Multicentric Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exploring the Potential of Robotic Telesurgery in Remote Settings
Telesurgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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).
This will be measured by the investigator from the start of the surgical procedure through the completion of the surgical procedure.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

July 30, 2033

Study Registration Dates

First Submitted

June 18, 2025

First Submitted That Met QC Criteria

August 16, 2025

First Posted (Actual)

August 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2294288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to publish multiple articles during the study, using the full de-identified dataset from all patients or focusing on specific subsets of the data to highlight particular types of surgeries or groups of procedures.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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