Exploring the Potential of Robotic Telesurgery in Remote Settings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-14

Study Completion Date

2033-07-30

Brief Summary

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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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Detailed Description

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Conditions

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Prostate Carcinoma Prostate Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Exploring the Potential of Robotic Telesurgery in Remote Settings

Telesurgery

Group Type EXPERIMENTAL

Telesurgery utilizing Microport Medbot Robotic Platform

Intervention Type DEVICE

A robotic surgery for prostate disease via telesurgery, where a highly trained surgeon performs the operation remotely using a secure internet connection.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No