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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953277
First Posted: August 6, 2009
Last Update Posted: May 21, 2015
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.
Information provided by (Responsible Party):
AxoGen, Inc
August 4, 2009
August 6, 2009
May 21, 2015
August 2009
April 2015   (Final data collection date for primary outcome measure)
Surgeon Assessment of Technical Feasibility [ Time Frame: At time of surgery ]
Same as current
Complete list of historical versions of study NCT00953277 on ClinicalTrials.gov Archive Site
  • Erectile Recovery Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  • Continence Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  • Quality of Life Questionnaire [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
  • Adverse Events [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ]
Same as current
Not Provided
Not Provided
 
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Peripheral Nerve Injury
  • Prostate Cancer
  • Radical Prostatectomy
  • Nerve Reconstruction
  • Cavernous Nerve Injury
Other: Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
Experimental: Avance Nerve Graft
Processed Human Nerve Tissue Scaffold
Intervention: Other: Processed Human Nerve Tissue Scaffold
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2015
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00953277
ANG-CP-003
No
Not Provided
Not Provided
AxoGen, Inc
AxoGen, Inc
Not Provided
Principal Investigator: Joseph J Smith, MD Vanderbilt Univerisity
AxoGen, Inc
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP