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 | Recruiting Phase 2 FDA Device

• 1 other identifier: 2025-05-021-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Mean Traction Force (Newton, N)

  intraoperatively

• Total Instrument Path Length (meters, m)

  intraoperatively

Study Arms (2)

Force-feedback on

EXPERIMENTAL

Device: Force-feedback on

Force-feedback off

SHAM COMPARATOR

Device: Forece-feedback off

Interventions

Force-feedback on DEVICE

In this study, the "Force-Feedback ON" intervention refers to performing robotic-assisted radical prostatectomy using the da Vinci 5 (dV5) system with its haptic feedback function activated. When this mode is ON, miniature force sensors built into the robotic instruments continuously detect the mechanical resistance encountered at the instrument tips and transmit it back to the surgeon's hand controllers in real time. This tactile feedback allows the operator to feel the intensity and direction of traction or pressure applied to tissues, enabling finer motion control, reduced tissue stress, and safer dissection. In contrast, when Force Feedback is OFF, the surgeon relies solely on visual cues, as in all previous-generation robotic systems. Thus, "Force-Feedback ON" represents an active tactile-sensing mode designed to enhance precision, promote gentler handling, and improve training efficiency during robotic surgery.

Force-feedback on

Forece-feedback off DEVICE

Off force-feedback function

Force-feedback off

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 for study participation by the principal investigator (e.g., cognitive impairment affecting consent or follow-up).

Sponsors & Collaborators

• Seong Soo Jeon: lead

Study Sites (1)

Samsung Medical Center

Soeul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Jiwoong Yu Clinical professor

CONTACT

821068887981; jiwoong082.yu@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

KR (1)