NCT00953277CompletedPhase 4
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
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Axogen Corporation
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Surgeon Assessment of Technical Feasibility
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 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 Criteria
- •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.
Outcomes
Primary Outcomes
Surgeon Assessment of Technical Feasibility
Time Frame: At time of surgery
Secondary Outcomes
- Erectile Recovery Rates(Month 1, 3, 6, 9, 12, 18 and 24)
- Adverse Events(Month 1, 3, 6, 9, 12, 18 and 24)
- Quality of Life Questionnaire(Month 1, 3, 6, 9, 12, 18 and 24)
- Continence Rates(Month 1, 3, 6, 9, 12, 18 and 24)
Investigators
Study Sites (2)
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