Remote robotic prostate surgery using telesurgery technology
Advancing Humanitarian Healthcare: Exploring the Potential of Robotic Telesurgery in Remote Settings - A Multicentric Prospective Study
NA · AdventHealth · NCT07130708
This trial will try using robotic telesurgery—where a specialist operates remotely over a secure internet link—for adults who need robotic prostate surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | AdventHealth (other) |
| Locations | 1 site (Celebration, Florida) |
| Trial ID | NCT07130708 on ClinicalTrials.gov |
What this trial studies
This interventional trial uses the Microport Medbot robotic platform to allow a remote surgeon to perform robotic radical or simple prostatectomy on patients located at AdventHealth Celebration. Procedures are done over a secure, high-bandwidth connection while investigators collect data on intraoperative safety, perioperative outcomes, and technical performance measures such as latency and connection stability. The study enrolls adults aged 18–90 with localized prostate cancer or benign prostatic disease who are appropriate candidates for robotic surgery and who lack routine access to on-site robotic expertise. The protocol also documents workflow adaptations and explores telesurgery's potential role in surgical training.
Who should consider this trial
Good fit: Adults 18–90 with a confirmed indication for robotic radical prostatectomy for localized prostate cancer (ICD-10 C61) or for robotic simple prostatectomy for benign prostatic disease (ICD-10 N40) who lack routine access to robotic surgery and can travel to the study site and provide informed consent.
Not a fit: Patients with advanced or metastatic prostate cancer, unclear or unspecified urologic diagnoses, contraindications to robotic surgery or general anesthesia, or those unable to be physically present at the AdventHealth site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, telesurgery could expand access to expert robotic prostate surgery for patients in remote or underserved areas without requiring the specialist to be on-site.
How similar studies have performed: There have been isolated successful demonstrations and small pilots of telesurgery, including historic transcontinental cases, but large-scale clinical evidence for routine remote robotic prostatectomy remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Celebration, Florida
- AdventHealth — Celebration, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Carcinoma, Prostate Disease, Robotic Prostatectomy, Prostate Cancer, Telesurgery