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

Axogen Corporation1 site in 1 country12 target enrollmentAugust 2009

ConditionsPeripheral Nerve Injury Prostate Cancer Radical Prostatectomy Nerve Reconstruction Cavernous Nerve Injury

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Peripheral Nerve Injury
Sponsor: Axogen Corporation
Enrollment: 12
Locations: 1
Primary Endpoint: Surgeon Assessment of Technical Feasibility
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 2015

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Axogen Corporation

Responsible Party

Sponsor

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;