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NCT Number: NCT07564102

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location contact

Monali Fatterpekar, PhD

CONTACT

[email protected]

212-241-7005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

Prostatectomy without dMD-002

Primary outcomes

  1. Mean IIEF-EF scores

    Time frame: 6 months postoperatively

Secondary outcomes

  1. Mean EHS score

    Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months

  2. Mean SHIM score

    Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months

  3. 24-hour pad weight test

    Time frame: Screening, 6 weeks, and 3 months

  4. Number of Incontinence Episodes/Day

    Time frame: Screening, 6 weeks, and 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mochida Public Relations

CONTACT

[email protected]

Nozomu Watanabe

CONTACT

[email protected]

901-666-1308

Sponsors and collaborators

Lead sponsor

Mochida Medical USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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