Exploring the Potential of Robotic Telesurgery in Remote Settings
Recruiting · NCT07130708 · Interventional (participants receive a specific treatment) · Lead sponsor: AdventHealth
View the official record on ClinicalTrials.gov →Interventions studied
Telesurgery utilizing Microport Medbot Robotic Platform
What this trial is about
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 can take part
Age range
18 Years to 90 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- 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
Where it is running
1 location listed across 1 US state.
- AdventHealth - Celebration, Florida, United States