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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 19 and up Men only

Force feedback on the da Vinci 5 robot to improve learning and safety in radical prostatectomy

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

Run by Samsung Medical Center · NCT07247175 · Data updated 2026-11-12

This trial will test whether haptic (force) feedback on the da Vinci 5 robot helps surgeons learn and perform robot-assisted radical prostatectomy more safely in men with localized prostate cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Ages19 Years and up
SexMen only
Enrollment60 (estimated)
SponsorSamsung Medical Center
Academic / other
Locations1 site (Soeul)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedJune 30, 2026
Study endsDecember 31, 2027
Registry record updatedFebruary 25, 2026
Trial IDNCT07247175 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 19 or older with histologically confirmed clinically localized prostate cancer (cT1–T3a, N0, M0), suitable for robot-assisted radical prostatectomy at Samsung Medical Center and fit for general anesthesia (ASA I–III) with baseline erectile function (IIEF-5 ≥12) are ideal candidates.

Probably not a fit

Patients with locally advanced or metastatic disease (≥T3b, N1, M1), prior pelvic radiotherapy or androgen-deprivation therapy, very large prostate volume (≥60 cc), or who are unfit for robotic surgery are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective Phase 2 trial at Samsung Medical Center will enroll 60 men with clinically localized prostate cancer undergoing robot-assisted radical prostatectomy. Two surgeons (one expert and one trainee) will each perform 30 cases with the dV5 system, and for each surgery the Force Feedback feature will be randomly set ON or OFF. Primary endpoints include mean traction force and total instrument path length during seminal vesicle dissection, with secondary endpoints capturing other surgical performance and safety metrics. The trial tests whether real-time haptic feedback reduces excessive tissue traction and improves precision during the learning curve compared with no force feedback.

Why it matters

Potential benefit: If successful, haptic feedback could reduce excessive tissue traction, lower intraoperative tissue injury, and speed surgical skill acquisition, improving precision and safety during RARP.

How similar studies have gone: Preclinical and simulation reports have shown that haptic feedback can reduce applied forces and improve precision, but randomized clinical evidence in RARP is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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).

Where it's running

  • Samsung Medical Center
    Soeul, South Korea     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.