Sponsor:
Icahn School of Medicine at Mount Sinai
Code:
NCT06945315
Conditions
Prostate Cancer
Erectile Dysfunction
Eligibility Criteria
Sex: Male
Age: 18+
Healthy Volunteers: Not accepted
Interventions
RALP (Robotic-assisted radical prostatectomy)
SAFE (Saline assisted fascial engorgement)
Brief summary:
Conditions
Prostate Cancer
Erectile Dysfunction
Study ID
NCT06945315
Start date
Nov 14, 2023
Status verified date
Apr, 2025
Completion date
Jul 14, 2027
Anticipated
Primary completion date
Jul 14, 2027
Anticipated
Eligibility Criteria
Sex: Male
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
196 participants
Anticipated
Allocation
Randomized
Intervention Model
Single group
Primary purpose
Prevention
Arms
experimental: RALP with SAFE Technique
active comparator: RALP without SAFE Technique
Interventions
RALP (Robotic-assisted radical prostatectomy)
SAFE (Saline assisted fascial engorgement)
Primary outcome measure
Central contacts
Locations
Mount Sinai Hospital
Recruiting
New York, New York, United States, 10029
Contacts
Principal Investigator:
Ashutosh Tewari
Sponsor
Icahn School of Medicine at Mount Sinai
Last update posted
Apr 25, 2025
Last verified
Apr, 2025
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.