Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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) is a Phase 2 interventional studying Prostate Cancer, sponsored by Seong Soo Jeon. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Prostate Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prostate Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male patients aged ≥19 years. diagnosed by tissue sample (biopsy-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 willing to sign a consent form for participation after full explanation of the study. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

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.

DEVICE

Forece-feedback off

Off force-feedback function

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Samsung Medical Center

Soeul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07247175), the sponsor (Seong Soo Jeon), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07247175 clinical trial studying?

Who can participate in NCT07247175?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07247175?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07247175. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07247175. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.