Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
AxoGen, Inc
Information provided by (Responsible Party):
AxoGen, Inc
ClinicalTrials.gov Identifier:
NCT00953277
First received: August 4, 2009
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Nerve Injury Prostate Cancer Radical Prostatectomy Nerve Reconstruction Cavernous Nerve Injury |
Other: Processed Human Nerve Tissue Scaffold |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Peripheral Nerve Disorders
Plastic and Cosmetic Surgery
Prostate Cancer
U.S. FDA Resources
Further study details as provided by AxoGen, Inc:
Primary Outcome Measures:
- Surgeon Assessment of Technical Feasibility [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Erectile Recovery Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
- Continence Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
- Quality of Life Questionnaire [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Avance Nerve Graft
Processed Human Nerve Tissue Scaffold
|
Other: Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | AxoGen, Inc |
| ClinicalTrials.gov Identifier: | NCT00953277 History of Changes |
| Other Study ID Numbers: | ANG-CP-003 |
| Study First Received: | August 4, 2009 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by AxoGen, Inc:
|
Nerve Repair Erectile Function Prostate Cancer Robot Assisted Laparoscopic Prostatectomy Continence |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013