CClinicalTrials.gg
Sign In
Not yet recruitingNCT07564102Updated May 15, 2026

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

A Phase 1/2 interventional study of dMD-002 and Control in Prostate Cancer, sponsored by Mochida Medical USA, Inc.. Not yet recruiting at 1 site in United States. Open to male participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Mochida Medical USA, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 74 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • dMD-002
  • Nerve Repair
  • Cavernous Nerve
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Mochida Medical USA, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Device: dMD-002

  • Sham comparator
    Control group

    Other: Control

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

06

What researchers measure

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

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07564102
Lead sponsor
Mochida Medical USA, Inc.
Responsible party
Sponsor
First posted
May 4, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
May 15, 2026

Study contacts

Nozomu Watanabe
Contact
dmd00203@mochida-medical.com
901-666-1308
Mochida Public Relations
Contact
webmaster@mochida.co.jp

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Neoplasms→

Start the discussion