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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

RecruitingPhase 2Ages 19 Years - anyMaleSeong Soo Jeon
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In plain words

What the trial is, and whether it could suit you

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 l

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male patients aged โ‰ฅ19 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 โ‰ฅ12 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 โ‰ฅT3b, N1, or M1\*\*). Prostate volume โ‰ฅ60 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 โ‰ฅ 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).
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What it tests

  • Force-feedback on
  • Forece-feedback off
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Where

1 site
Samsung Medical Center
Soeul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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