The Impact of Force Feedback in the dV5 Robotic Surgical System on Learning Curve and Safety in R… (NCT07247175) | Clinical Trial Compass
RecruitingPhase 2
The Impact of Force Feedback in the dV5 Robotic Surgical System on Learning Curve and Safety in Robot-Assisted Radical Prostatectomy - A Prospective, Single-Center, Investigator-Initiated Clinical Trial
South Korea60 participantsStarted 2026-01-01
Plain-language summary
This single-center, investigator-initiated prospective clinical study aims to evaluate the impact of the Force Feedback function of the da Vinci 5 (dV5) robotic surgical system on surgical skill acquisition and intraoperative safety during robot-assisted radical prostatectomy (RARP). Although robotic surgery is well established in urology, the absence of tactile sensation remains a major limitation of previous systems. The new dV5 platform incorporates real-time haptic (force) feedback, potentially reducing excessive tissue traction and improving surgical precision.
A total of 60 patients with clinically localized prostate cancer will be enrolled at Samsung Medical Center. Two surgeons (one faculty and one trainee) will each perform 30 RARP cases, with Force Feedback ON/OFF randomly assigned for each case. The primary endpoints are (1) mean traction force and (2) total instrument path length during seminal vesicle dissection. Secondary endpoints include surgical performance metrics (time, clutch counts), intraoperative safety, postoperative complications, and patient-reported outcomes (IPSS, IIEF-5, EPIC-CP, ICIQ-UI SF). Data will be analyzed using mixed-effects models accounting for surgeon-level random effects.
This study seeks to provide quantitative evidence on how Force Feedback enhances surgical learning efficiency, precision, and patient safety in next-generation robotic prostate surgery.
Who can participate
Age range
19 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male patients aged ≥19 years.
Histologically confirmed localized prostate cancer, clinical stage T1-T3a, N0, M0.
Scheduled to undergo robot-assisted radical prostatectomy (RARP) at Samsung Medical Center.
No radiologic evidence of distant metastasis, and disease deemed surgically resectable via robotic approach.
Medically fit for general anesthesia and laparoscopic surgery, classified as ASA physical status I-III.
Baseline erectile function preserved, defined as IIEF-5 ≥12 within 6 months prior to surgery.
Provided written informed consent for participation after full explanation of the study.
Exclusion Criteria:
* Locally advanced or metastatic prostate cancer (clinical stage ≥T3b, N1, or M1\*\*).
Prostate volume ≥60 cc on preoperative MRI, which may complicate robotic dissection standardization.
History of pelvic radiotherapy for any malignancy.
Previous androgen deprivation therapy (ADT) or other hormonal therapy for prostate cancer.
History of prior prostate surgery, such as TURP or HoLEP.
History of spinal cord injury or major pelvic surgery that may alter pelvic anatomy.
Medical contraindications to robotic/laparoscopic surgery or general anesthesia (e.g., severe cardiopulmonary disease, ASA ≥ IV).
Anatomic limitations (e.g., extreme obesity or deformity) precluding safe robotic access.
Device or software malfunction preventing proper activation or deactivation of the Force Feedback system.
Any other condition deemed inappropriate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.