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Looking for volunteers

SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

NCT06945315 · Icahn School of Medicine at Mount Sinai · Updated 25 April 2025

What is being tested
RALP (Robotic-assisted radical prostatectomy); SAFE (Saline assisted fascial engorgement)
For
Prostate Cancer; Erectile Dysfunction
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years and older. About 196 people. The full rules are on the registry page.
Where
United States
When
Starts or started 14 Nov 2023, ends 14 July 2027. Registered 25 April 2025.
Results
None posted yet.

In the researchers' words

Robotic-assisted radical prostatectomy (RALP) has become the standard of care in the management of localized prostate cancer. However, post-prostatectomy erectile dysfunction (ED) and urinary incontinence still pose a challenge that adversely affects the patient's quality of life. Hydrodissection (HD) was introduced in 1987 in the medical field and it was tested for the first time during a retropubic radical prostatectomy back in 2005. Since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of neuropraxia. In an effort to achieve a balance between oncological excision and functional preservation, prostate surgery is evolving to incorporate intraoperative real-time evaluation of extracapsular extension. Recently, a micro-ultrasound operating at 29 MHz has been introduced. It provides a resolution down to 70 μ to assess the glandular pattern and cellular density of the prostatic tissue. Given the experience in more than a thousand cases with this technology, and the growing literature showing promising results in the detection and staging of prostate cancer; the researchers decided to implement this tool as guidance for hydrodissection of the layers of the lateral prostatic fascia. Robotic-Assisted Laparoscopic Prostatectomy and SAFE (Saline assisted fascial engorgement) nerve…
ClinicalTrials.gov, NCT06945315

Sites

  • Mount Sinai HospitalNew York, New York, United States