Clinical trial · Interventional
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy
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
NCT07564102CI-TRIAL-00111693not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| dMD-002 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- interventionNames
- Device: dMD-002
- type
- SHAM_COMPARATOR
- label
- Control group
- interventionNames
- Other: Control
Primary outcomes (1)
- measure
- Mean IIEF-EF scores
- timeFrame
- 6 months postoperatively
Secondary outcomes (4)
- measure
- Mean EHS score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.