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

February 24, 2026 updated by: Seong Soo Jeon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-institution, investigator-initiated clinical trial investigates how the Force Feedback (haptic sensing) technology in the da Vinci 5 (dV5) robotic surgery platform influences technical skill acquisition and safety in robot-assisted radical prostatectomy (RARP). The study is conducted at Samsung Medical Center (Seoul, Korea) under the supervision of Professor Seong Soo Jeon and Dr. Jiwoong Yu from the Department of Urology.

Robotic-assisted surgery has revolutionized minimally invasive prostate cancer treatment, but conventional robotic systems (e.g., da Vinci Xi) lack tactile feedback, forcing surgeons to rely solely on visual cues. This limitation may lead to excessive force application and increase the risk of tissue injury. The dV5 system introduces a Force Feedback mechanism that allows surgeons to feel real-time resistance transmitted through the robotic arms. Preclinical reports suggest this reduces applied forces by up to 40-50% and improves precision, especially during the learning phase. However, objective clinical data quantifying these benefits are limited.

The present trial will enroll 60 patients diagnosed with clinically localized prostate cancer (cT1-T3a, N0, M0) eligible for RARP. Two surgeons-a senior faculty (expert) and a urology resident (trainee)-will each perform 30 RARP cases. For each surgery, the Force Feedback function will be randomly assigned (ON vs. OFF) while maintaining identical operative conditions. The seminal vesicle dissection step is chosen as the standardized assessment phase since it is technically demanding yet safe for educational evaluation.

Primary endpoints are:

Mean traction force applied to tissue (N)

Total instrument path length (m) during seminal vesicle dissection

Secondary endpoints include:

Surgical performance metrics: operative time, clutch counts, peak force, efficiency indicators, and cumulative sum (CUSUM) learning curves.

Safety parameters: estimated blood loss, complications (graded by Clavien-Dindo), hospital stay, and biochemical recurrence.

Patient-reported outcomes: urinary, sexual, and overall quality of life assessed by validated questionnaires (IPSS, IIEF-5, EPIC-CP, ICIQ-UI SF).

Procedural efficiency metrics such as lens-cleaning frequency and suction count.

All operations will be video-recorded and digitally logged using dV5 Case Insight software, which captures objective performance indicators (OPIs) including instrument trajectory, applied force, and clutch frequency. Statistical analysis will use linear mixed-effects models with Force Feedback status and case sequence as fixed effects, and surgeon ID as a random effect, allowing adjustment for intra-surgeon correlations and learning effects.

Safety monitoring follows institutional IRB and KGCP guidelines. All adverse events (AEs) and device deficiencies will be documented, with serious adverse events (SAEs) reported within 24 hours. Standard perioperative management and intraoperative supervision by experienced faculty will ensure patient safety.

This study is designed as a pilot exploratory analysis that integrates human performance data, haptic sensor output, and clinical outcomes. Findings will offer the first objective evidence on how haptic feedback influences both novice and expert robotic surgeons in terms of force modulation, precision, efficiency, and safety. The results may guide the optimization of training curricula and inform the development of future robotic platforms incorporating tactile intelligence.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Force-feedback on
Device: Force-feedback on

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.
Sham Comparator: Force-feedback off
Device: Forece-feedback off
Off force-feedback function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Traction Force (Newton, N)
Time Frame: intraoperatively
intraoperatively
Total Instrument Path Length (meters, m)
Time Frame: intraoperatively
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seong Soo Jeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-05-021-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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