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RECRUITINGINTERVENTIONAL

Exploring the Potential of Robotic Telesurgery in Remote Settings

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

AdventHealth
Celebration, Florida, United States