Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00953277
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):
Axogen Corporation

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Surgeon Assessment of Technical Feasibility [ Time Frame: At time of surgery ]

Secondary Outcome Measures :
  1. Erectile Recovery Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  2. Continence Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  3. Quality of Life Questionnaire [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  4. Adverse Events [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953277

Layout table for location information
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Axogen Corporation
Layout table for investigator information
Principal Investigator: Joseph J Smith, MD Vanderbilt Univerisity

Layout table for additonal information
Responsible Party: Axogen Corporation Identifier: NCT00953277    
Other Study ID Numbers: ANG-CP-003
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Axogen Corporation:
Nerve Repair
Erectile Function
Prostate Cancer
Robot Assisted Laparoscopic Prostatectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Peripheral Nerve Injuries
Wounds and Injuries
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System