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

NCT07564102 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: dMD00203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

dMD-002; Nerve Repair; Cavernous Nerve

Outcome Measures

Primary Outcomes (1)

• Mean IIEF-EF scores

  6 months postoperatively

Secondary Outcomes (4)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Device: dMD-002

Control group

SHAM COMPARATOR

Other: Control

Interventions

dMD-002 DEVICE

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.

Treatment group

Control OTHER

Prostatectomy without dMD-002

Control group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mochida Medical USA, Inc.: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Nozomu Watanabe

CONTACT

901-666-1308; dmd00203@mochida-medical.com

Mochida Public Relations

CONTACT

webmaster@mochida.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)