Force feedback on the da Vinci 5 robot to improve learning and safety in radical prostatectomy
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
PHASE2 · Samsung Medical Center · NCT07247175
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
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | Male |
| Sponsor | Samsung Medical Center (other) |
| Locations | 1 site (Soeul) |
| Trial ID | NCT07247175 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Preclinical and simulation reports have shown that haptic feedback can reduce applied forces and improve precision, but randomized clinical evidence in RARP is limited.
Eligibility criteria
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 this trial is running
Soeul
- Samsung Medical Center — Soeul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jiwoong Yu Clinical professor
- Email: jiwoong082.yu@samsung.com
- Phone: 821068887981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer