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dMD-002 for Cavernous Nerve Injury After Prostatectomy

This study is testing a device called dMD-002 in men aged 40 to 74 who have prostate cancer and are having a radical prostatectomy (surgery to remove the prostate gland). The dMD-002 device is a sheet that is implanted to cover nerve injuries, tears, or defects in the cavernous nerve, which can be damaged during prostatectomy. The goal is to see if dMD-002 can help repair these nerves. Researchers will compare men who receive dMD-002 to those who have the surgery without it. The main way they will measure success is by looking at scores on a questionnaire about erectile function (IIEF-EF scores) 6 months after surgery. This is a pilot study to help plan a larger future study. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It compares dMD-002 to not using the device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after surgery to measure erectile function scores.

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NCT07564102

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

Not Yet Recruiting
PHASE1Ages 40–74InterventionalTreatment
Mochida Medical USA, Inc.
~30 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:dMD-002Control

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean IIEF-EF scores
Measured over 6 months postoperatively

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Nozomu Watanabe
[email protected]
901-666-1308
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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Mean IIEF-EF scores6 months postoperatively