Status:
COMPLETED
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
Lead Sponsor:
Axogen Corporation
Conditions:
Peripheral Nerve Injury
Prostate Cancer
Eligibility:
MALE
18-70 years
Phase:
PHASE4
Brief 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 w...
Eligibility Criteria
Inclusion
- ≥ 18 years of age, but ≤70 years of age;
- IIEF EF Domain\*1 score ≥ 22;
- be able to effectively communicate with study personnel;
- be considered by the physician to be available for subsequent visits;
- be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;
- sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and
- require radical prostatectomy.
Exclusion
- prior surgery in the last 6 months which could affect sexual function;
- history of Peyronie's disease;
- significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);
- treatment for major psychiatric disorders;
- history of penile implant or prosthesis;
- history of diabetic neuropathy;
- life expectancy of less than two years;
- concurrently involved in another investigational study;
- uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening;
- currently receiving or planned treatment with chemotherapy or radiation therapy;
- diagnosis of bony metastasis;
- known allergy or severe intolerance to PDE-5 inhibitors; or
- cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00953277
Start Date
August 1 2009
End Date
April 1 2015
Last Update
August 12 2024
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232