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NCT06945315 · ClinicalTrials.gov registry record · Phase 3
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
A Phase 3 study of Prostate Cancer and Erectile Dysfunction, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 196
- Enrollment target
- 1
- Study location
NCT06945315 is a Phase 3 study of Prostate Cancer and Erectile Dysfunction that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 196 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06945315, a Phase 3 study of Prostate Cancer and Erectile Dysfunction, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 196 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE RALP (Robotic-assisted radical prostatectomy)
- DRUG SAFE (Saline assisted fascial engorgement)
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2027-07-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06945315
The ClinicalTrials.gov registry entry for NCT06945315 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (68% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which RALP (Robotic-assisted radical prostatectomy) is the first listed.
NCT06945315 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06945315 about?
NCT06945315 is a clinical study titled "SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)". 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 (H...
What is the current status of trial NCT06945315?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2023-11-14. Estimated completion is 2027-07-14.
What conditions does trial NCT06945315 study?
This clinical trial studies the following conditions: Prostate Cancer, Erectile Dysfunction.
What interventions are being tested in trial NCT06945315?
The interventions under investigation include: RALP (Robotic-assisted radical prostatectomy) (PROCEDURE), SAFE (Saline assisted fascial engorgement) (DRUG).
Who is sponsoring clinical trial NCT06945315?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06945315 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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