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

Part of paid clinical trials in New York, New York.

Sponsor
Mochida Medical USA, Inc.
Study ID
NCT07564102
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 74 Years
Healthy Volunteers
Not accepted

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.
  • Control — OTHER
    Prostatectomy without dMD-002

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
  • Sham Comparator: Control group

Primary Outcome Measure

Mean IIEF-EF scores [ Time Frame: 6 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Monali Fatterpekar, PhD
[email protected]
212-241-7005

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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