Back to resultsStudy of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
Primary Purpose
Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Processed Human Nerve Tissue Scaffold
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring Nerve Repair, Erectile Function, Prostate Cancer, Robot Assisted Laparoscopic Prostatectomy, Continence
Eligibility 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.
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avance Nerve Graft
Arm Description
Processed Human Nerve Tissue Scaffold
Outcomes
Primary Outcome Measures
Surgeon Assessment of Technical Feasibility
Secondary Outcome Measures
Erectile Recovery Rates
Continence Rates
Quality of Life Questionnaire
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00953277
Brief Title
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axogen Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury
Keywords
Nerve Repair, Erectile Function, Prostate Cancer, Robot Assisted Laparoscopic Prostatectomy, Continence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avance Nerve Graft
Arm Type
Experimental
Arm Description
Processed Human Nerve Tissue Scaffold
Intervention Type
Other
Intervention Name(s)
Processed Human Nerve Tissue Scaffold
Intervention Description
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
Primary Outcome Measure Information:
Title
Surgeon Assessment of Technical Feasibility
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Erectile Recovery Rates
Time Frame
Month 1, 3, 6, 9, 12, 18 and 24
Title
Continence Rates
Time Frame
Month 1, 3, 6, 9, 12, 18 and 24
Title
Quality of Life Questionnaire
Time Frame
Month 1, 3, 6, 9, 12, 18 and 24
Title
Adverse Events
Time Frame
Month 1, 3, 6, 9, 12, 18 and 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Smith, MD
Organizational Affiliation
Vanderbilt Univerisity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
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