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
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.
Eligibility
- Age range
- 40–74 years
- Sex
- Male
- 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: * 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.
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
Location
- Icahn School of Medicine at Mount SinaiNew York, New York