dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy
NCT07564102 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-15
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.
Conditions
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
Sponsors & Collaborators
-
Mochida Medical USA, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 74 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-09-30
- Completion
- 2028-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05603208 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04600856 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05614804 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02746120 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07154160 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00790621 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05267561 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02576210 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07120412 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06042101 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07421362 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06015607 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05694702 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06100861 ·Status: WITHHELD
-
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
NCT07211035 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02070601 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07311720 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05613543 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04680312 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04786912 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06156696 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06709261 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04773912 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07553403 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07324031 ·Status: WITHHELD