Robotic Telesurgery in Remote Healthcare Settings
Telesurgery utilizing Microport Medbot Robotic Platform
Urogenital Diseases+2
+ Genital Diseases
+ Genital Diseases, Male
Device Feasibility Study
Summary
Study start date: June 14, 2025
Actual date on which the first participant was enrolled.This study is exploring the use of robotic telesurgery, which is a type of surgery performed by a specialized surgeon from a distance using a secure internet connection. The main goal is to determine how safe and effective this method is when applied in real hospital settings. By assessing its functionality in different environments and identifying potential technical issues, like internet speed or delays, the study aims to improve surgical care in remote areas. Additionally, this research is important as it could lead to the development of new training methods for upcoming surgeons. Participants in this study will be involved in surgeries where a surgeon operates remotely using robotic technology. The study will monitor how well the surgery is performed and any issues that arise during the procedure. It will evaluate the technical aspects of telesurgery, focusing on factors like internet connectivity and any delays that might affect the surgery. By analyzing these aspects, the study hopes to enhance the effectiveness and reliability of telesurgery, ultimately benefiting both patients and medical professionals.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location