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dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy

dMD-002 US Pilot Study A Single-center, Randomized, Double-blind, Pilot Study to Assess the Efficacy and Safety of dMD-002 in Patients After Radical Prostatectomy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 74 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small U.S. study tests dMD-002, a sheet used to repair nerves, in people with nerve injury after surgery to remove the prostate. It focuses on nerves that help with erections. The study will help decide what to measure and when in a future study.

The purpose of this study is to conduct a US Pilot study of dMD-002 as a peripheral nerve repair sheet in patients with cavernous nerve injury following radical prostatectomy. The study will determine which endpoints and timepoints will be used for the pivotal study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer.
  • Are scheduled for robot-assisted surgery to remove the prostate, with plans to save nerves on one or both sides.

Who can't join

  • Are receiving radiation, hormone treatment, or other cancer treatment before or after surgery.
  • Have had a device placed in the penis to help with erections.
  • Have had prostate surgery or procedures using a scope through the urine tube, lasers, microwaves, radio waves, or freezing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients diagnosed with prostate cancer. * Patients scheduled to undergo a robot-assisted radical prostatectomy (including either bilateral-nerve sparing or unilateral-nerve sparing) for treatment of prostate cancer. etc. Exclusion Criteria: * Patients undergoing pre-surgery or post-surgery radiation therapy, hormone therapy, or anti-cancer therapy. * Patients who have used a penile prosthesis implantation. * Patients with a history of transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, cryoablation, or other prostate surgery. etc.

Study sites (1)

NY