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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and well robotic telesurgery works in hospitals. Telesurgery lets a surgeon use a secure internet connection to operate on a patient in another location. It is for adults ages 18–90 who need robotic surgery for certain prostate problems and do not usually have access to it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–90 years old, of any sex.
  • Have prostate cancer that has not spread and is suitable for robotic surgery to remove the whole prostate, OR have a noncancerous prostate problem suitable for robotic surgery to remove part of the prostate.
  • Have the prostate problem confirmed by an exam, scans, and/or tests of tissue.
  • Are scheduled for robotic surgery for the qualifying urinary system or prostate problem.
  • Do not usually have access to robotic surgery.
  • Are willing to join the study.
  • Can understand the study plan.

Who can't join

  • Have an unclear or unspecified urinary system or prostate problem.
  • Are judged by the care team to have too high a risk for robotic surgery, including uncontrolled heart, lung, or metabolism problems.
  • Have a severe risk from anesthesia, the medicine used during surgery, rated ASA Class IV or higher.
  • Are in another study testing a treatment that could affect surgery safety or results.
  • Are unwilling or unable to follow the care and visit schedule before and after surgery.
  • Are under 18 years old.
  • Are a prisoner.
  • Have problems with thinking or cannot make decisions for yourself.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (1)

FL