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Not yet recruiting NCT07564102

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

Phase I / Phase II Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dMD-002, Control.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 40 years — 74 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device dMD-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.
  • Other Control
    Prostatectomy without dMD-002

Primary outcome measures

  • Mean IIEF-EF scores [Time frame: 6 months postoperatively]
Secondary outcome measures (4)
  • Mean EHS score [Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months]
  • Mean SHIM score [Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months]
  • 24-hour pad weight test [Time frame: Screening, 6 weeks, and 3 months]
  • Number of Incontinence Episodes/Day [Time frame: Screening, 6 weeks, and 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT07564102 · dMD00203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗