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

NCT ID: NCT00953277

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2015-04-30

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.

Conditions

Peripheral Nerve Injury; Prostate Cancer; Radical Prostatectomy; Nerve Reconstruction; Cavernous Nerve Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avance Nerve Graft

Processed Human Nerve Tissue Scaffold

Group Type: EXPERIMENTAL

Processed Human Nerve Tissue Scaffold

Intervention Type: OTHER

Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Interventions

Processed Human Nerve Tissue Scaffold

Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Axogen Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph J Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Univerisity

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

ANG-CP-003

Identifier Type: -

Identifier Source: org_study_id