Trials / Completed
CompletedNCT00953277
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Axogen Corporation · Industry
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.
Conditions
- Peripheral Nerve Injury
- Prostate Cancer
- Radical Prostatectomy
- Nerve Reconstruction
- Cavernous Nerve Injury
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Processed Human Nerve Tissue Scaffold | Implantation of appropriate length of processed human nerve scaffold at the time of surgery. |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2009-08-06
- Last updated
- 2024-08-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00953277. Inclusion in this directory is not an endorsement.