Recruiting

Telesurgery

Sponsor:

AdventHealth

Code:

NCT07130708

Conditions

Prostate Carcinoma

Prostate Disease

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telesurgery utilizing Microport Medbot Robotic Platform

Study Details

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.

Conditions

Prostate Carcinoma

Prostate Disease

Study ID

NCT07130708

Start date

Jun 14, 2025

Status verified date

Jun, 2025

Completion date

Jul 30, 2033

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Exploring the Potential of Robotic Telesurgery in Remote Settings

Telesurgery

Interventions

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 measure

  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Locations

AdventHealth

Recruiting

Celebration, Florida, United States, 34747

Contacts

Research Nurse Manager

407-303-4933tadzia.harvey@adventhealth.com

Marcio Moschovas, MD, PhD

407-303-4673marcio.moschovas.md@adventhealth.com

Principal Investigator:

Vipul R Patel, MD

More Information

Sponsor

AdventHealth

Last update posted

Aug 19, 2025

Last verified

Jun, 2025

Keywords

  • Robotic Prostatectomy
  • Prostate Cancer
  • Telesurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2025-08-19.