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RecruitingNCT07130708Updated Aug 19, 2025

Exploring the Potential of Robotic Telesurgery in Remote Settings

An interventional study of Telesurgery utilizing Microport Medbot Robotic Platform in Prostate Carcinoma and Prostate Disease, sponsored by AdventHealth. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by AdventHealth · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Prostate Carcinoma
  • Prostate Disease

Keywords

  • Robotic Prostatectomy
  • Prostate Cancer
  • Telesurgery
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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Exploring the Potential of Robotic Telesurgery in Remote Settings

    Telesurgery

    Device: Telesurgery utilizing Microport Medbot Robotic Platform

Interventions

  • DeviceTelesurgery 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.

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What researchers measure

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.

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Rocco B, Moschovas MC, Saikali S, Gaia G, Patel V, Sighinolfi MC. Insights from telesurgery expert conference on recent clinical experience and current status of remote surgery. J Robot Surg. 2024 Jun 4;18(1):240. doi: 10.1007/s11701-024-01984-w. PubMed 38833111 ↗
  • Reddy SK, Saikali S, Gamal A, Moschovas MC, Rogers T, Dohler M, Marescaux J, Patel V. Telesurgery: A Systematic Literature Review and Future Directions. Ann Surg. 2025 Aug 1;282(2):219-227. doi: 10.1097/SLA.0000000000006570. Epub 2024 Oct 22. PubMed 39435556 ↗
  • Patel V, Dohler M, Marescaux J, Saikali S, Gamal A, Reddy S, Rogers T, Patel E, Oliva R, Satava R, Moschovas MC. Expanding Surgical Frontiers Across the Pacific Ocean: Insights from the First Telesurgery Procedures Connecting Orlando with Shanghai in Animal Models. Eur Urol Open Sci. 2024 Oct 21;70:70-78. doi: 10.1016/j.euros.2024.09.009. eCollection 2024 Dec. PubMed 39502103 ↗
  • Dohler M, Saikali S, Gamal A, Moschovas MC, Patel V. The crucial role of 5G, 6G, and fiber in robotic telesurgery. J Robot Surg. 2024 Nov 16;19(1):4. doi: 10.1007/s11701-024-02164-6. PubMed 39549181 ↗
  • Moschovas MC, Saikali S, Dohler M, Patel E, Rogers T, Gamal A, Marquinez J, Patel V. Advancing Telesurgery Connectivity Between North and South America: the first Remote Surgery Conducted Between Orlando and Sao Paulo in Animal Models. Int Braz J Urol. 2025 Jan-Feb;51(1):e20240601. doi: 10.1590/S1677-5538.IBJU.2024.0601. No abstract available. PubMed 39556854 ↗
  • Patel V, Moschovas MC, Marescaux J, Satava R, Dasgupta P, Dohler M. Telesurgery collaborative community working group: insights about the current telesurgery scenario. J Robot Surg. 2024 May 31;18(1):232. doi: 10.1007/s11701-024-01995-7. No abstract available. PubMed 38819496 ↗
  • Patel V, Marescaux J, Covas Moschovas M. The Humanitarian Impact of Telesurgery and Remote Surgery in Global Medicine. Eur Urol. 2024 Aug;86(2):88-89. doi: 10.1016/j.eururo.2024.04.029. Epub 2024 May 18. PubMed 38762391 ↗

Individual participant data

Plan to share: Undecided — 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.

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Registry details

Key details

Study ID
NCT07130708
Lead sponsor
AdventHealth
Responsible party
Vipul Patel, MD (Medical Director, AdventHealth Cancer Institute Urologic Oncology Program Medical Director, AdventhHealth Celebration Global Robotics Institute, AdventHealth) — Principal investigator
First posted
Aug 19, 2025
Start date
Jun 14, 2025
Primary completion
Sep 30, 2028 (estimated)
Completion
Jul 30, 2033 (estimated)
Last update
Aug 19, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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