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Search / Trial NCT06945315

SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Apr 24, 2025

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Robotic Assisted Laparoscopic Prostatectomy (Ralp) Safe (Saline Assisted Fascial Engorgement)

ClinConnect Summary

The SAFE Nerve Sparing Guided by Micro-ultrasound (MUS) clinical trial is exploring a new approach to help men with prostate cancer who may experience erectile dysfunction after surgery. The study aims to determine if a technique called hydrodissection, which uses normal saline solution and a special high-resolution ultrasound, can improve erectile function after a robotic-assisted prostatectomy. This method allows doctors to carefully evaluate the surrounding nerve structures during surgery, potentially leading to better outcomes for men’s sexual health after their treatment.

To participate in this trial, men aged 18 and older who are sexually active and have good erectile function before surgery (as measured by a specific questionnaire) may be eligible. Participants will undergo nerve-sparing surgery and will have their procedure guided by the advanced ultrasound. This study is beneficial for those looking to maintain their erectile function post-surgery while still effectively treating their prostate cancer. If you qualify and choose to participate, you can expect thorough monitoring and care throughout the process.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Age \> 18 years at the time of consent.
  • Men who are potent (SHIM ≥ 17) and sexually active, who are planned to undergo a grade 1, 2, or 3 nerve-sparing approaches, as per the grading system during RALP.
  • Ability to understand and the willingness to sign a written informed consent.
  • Exclusion Criteria:
  • Subjects who are candidates for salvage RALP
  • Subjects on androgen deprivation therapy (ADT)
  • Subjects in whom PDE5 inhibitors are contraindicated

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)

Principal Investigator

Study Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported