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dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy
Sponsor: Mochida Medical USA, Inc.
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.
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
Key Details
Gender
MALE
Age Range
40 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-08-01
Completion Date
2028-06-30
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
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.
Control
Prostatectomy without dMD-002
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States