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NCT07247175

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

Recruiting now Phase 2 Last updated 25 February 2026
What this trial tests

Phase 2 trial testing Force-feedback on in Prostate Cancer in 60 participants. Currently enrolling.

Timeline
1 January 2026
Primary endpoint
30 June 2026
31 December 2027

Quick facts

Lead sponsorSeong Soo Jeon
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date1 January 2026
Primary completion30 June 2026
Estimated completion31 December 2027
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seong Soo Jeon

Who can join

19 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

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Data sources for this page

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