Actively Recruiting
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
Led by Seong Soo Jeon · Updated on 2026-02-25
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 19 years or older
- Histologically confirmed localized prostate cancer, clinical stage T1 to T3a, N0, M0
- Scheduled for robot-assisted radical prostatectomy at Samsung Medical Center
- No evidence of distant metastasis and disease suitable for robotic surgery
- Medically fit for general anesthesia and laparoscopic surgery with ASA physical status I to III
- Preserved baseline erectile function with IIEF-5 score 12 or higher within 6 months prior to surgery
- Provided written informed consent after full explanation of the study
You will not qualify if you...
- Locally advanced or metastatic prostate cancer (clinical stage 3b or higher, N1, or M1)
- Prostate volume 60 cc or greater on preoperative MRI
- History of pelvic radiotherapy for any cancer
- Previous androgen deprivation or hormonal therapy for prostate cancer
- History of prior prostate surgery such as TURP or HoLEP
- History of spinal cord injury or major pelvic surgery altering pelvic anatomy
- Medical contraindications to robotic/laparoscopic surgery or general anesthesia (e.g., severe cardiopulmonary disease, ASA 4 or higher)
- Anatomic limitations preventing safe robotic access (e.g., extreme obesity or deformity)
- Device or software malfunction preventing proper use of Force Feedback system
- Any condition deemed inappropriate by the principal investigator, such as cognitive impairment affecting consent or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Soeul, South Korea
Actively Recruiting
Research Team
J
Jiwoong Yu Clinical professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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