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Tests treatment safety and results for Prostate Cancer
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
ClinicalTrials.gov ID: NCT07247175
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Soeul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Soeul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.