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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

NCT07247175 · Seong Soo Jeon · Updated 25 Feb 2026

What is being tested
Force-feedback on; Forece-feedback off
For
Prostate Cancer
Kind of study
Tests a treatment or device on volunteers. Phase 2.
Who can join
Ages 19 years and older. About 60 people. The full rules are on the registry page.
Where
South Korea
When
Starts or started 1 Jan 2026, ends 31 Dec 2027. Registered 25 Nov 2025.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT07247175

Sites

  • Samsung Medical CenterSoeul, South Korea