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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07564102

Enrollment

Registered

2026-05-04

Start date

2026-08-01

Completion date

2028-06-30

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

dMD-002, Nerve Repair, Cavernous Nerve

Brief summary

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.

Interventions

DEVICEdMD-002

The cut dMD-002 is implanted to cover the nerve injury, tear, or defect, and is fixed by suturing to the surrounding tissue in two or more places.

OTHERControl

Prostatectomy without dMD-002

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

40 Years to 74 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Mean IIEF-EF scores	6 months postoperatively

Secondary

Measure	Time frame
Mean EHS score	Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
Mean SHIM score	Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
24-hour pad weight test	Screening, 6 weeks, and 3 months
Number of Incontinence Episodes/Day	Screening, 6 weeks, and 3 months

Countries

United States

Contacts

CONTACTNozomu Watanabe

dmd00203@mochida-medical.com901-666-1308

CONTACTMochida Public Relations

webmaster@mochida.co.jp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026