SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

PHASE3RecruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

November 14, 2023

Primary Completion Date

July 14, 2027

Study Completion Date

July 14, 2027

Conditions
Prostate CancerErectile Dysfunction
Interventions
PROCEDURE

RALP (Robotic-assisted radical prostatectomy)

Robotic-assisted radical prostatectomy (RALP) is a standard surgical procedure for managing localized prostate cancer that focuses on prostate anatomy and surrounding structures to enable personalized surgeries. The procedure incorporates nerve-sparing techniques through careful dissection of the neurovascular bundle and can use a thermal and traction-free dissection to improve functional outcomes, particularly erectile function.

DRUG

SAFE (Saline assisted fascial engorgement)

SAFE (Saline assisted fascial engorgement) an innovative technique to achieve enhanced nerve-sparing outcomes among patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Essentially a new method of hydro dissection, SAFE involves an injection of 30 cc of normal saline solution between the layers of the periprostatic fascia after early release of the neurovascular bundle. This injection effectively pushes the nerves away from the prostate, enabling a dissection of the prostate that is atraumatic vis a vis the neural hammock.

Trial Locations (1)

10029

RECRUITING

Mount Sinai Hospital, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER