Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

Sponsor

Axogen Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00953277

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Injury Prostate Cancer Radical Prostatectomy Nerve Reconstruction Cavernous Nerve Injury	Other: Processed Human Nerve Tissue Scaffold	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Surgeon Assessment of Technical Feasibility [At time of surgery]

Secondary Outcome Measures

Erectile Recovery Rates [Month 1, 3, 6, 9, 12, 18 and 24]
Continence Rates [Month 1, 3, 6, 9, 12, 18 and 24]
Quality of Life Questionnaire [Month 1, 3, 6, 9, 12, 18 and 24]
Adverse Events [Month 1, 3, 6, 9, 12, 18 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.