SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
Public ClinicalTrials.gov record NCT06945315. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Robotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 preservation guided by Microultrasound (MUS) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (HD) on erectile function outcomes after RALP. This innovative approach consists of a transrectal ultrasound-guided HD using a high-resolution Microultrasound (MUS) (ExactVu micro-ultrasound, Exact Imaging, Markham, Canada). The technique will be applied to those patients who undergo grade 1, 2, or 3 NS approach taking into account the grading system proposed by Tewari et al. The hypothesis is that the SAFE technique could minimize the risk of a traumatic neurovascular bundle dissection while assessing the prostatic capsule integrity with a high-resolution MUS. The researchers also hypothesize that the use of SAFE along with RALP will optimize the post-surgery recovery of erectile function.
Study identification
- NCT ID
- NCT06945315
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 196 participants
Conditions and interventions
Conditions
Interventions
- RALP (Robotic-assisted radical prostatectomy) Procedure
- SAFE (Saline assisted fascial engorgement) Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 13, 2023
- Primary completion
- Jul 13, 2027
- Completion
- Jul 13, 2027
- Last update posted
- Apr 24, 2025
2023 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06945315, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06945315 live on ClinicalTrials.gov.