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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AxoGen, Inc
ClinicalTrials.gov Identifier:
NCT00953277
First received: August 4, 2009
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Peripheral Nerve Injury
Prostate Cancer
Radical Prostatectomy
Nerve Reconstruction
Cavernous Nerve Injury
Other: Processed Human Nerve Tissue Scaffold
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AxoGen, Inc:

Primary Outcome Measures:
  • Surgeon Assessment of Technical Feasibility [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Erectile Recovery Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
  • Continence Rates [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Month 1, 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: August 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953277

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
AxoGen, Inc
Investigators
Principal Investigator: Joseph J Smith, MD Vanderbilt Univerisity
  More Information

No publications provided

Responsible Party: AxoGen, Inc
ClinicalTrials.gov Identifier: NCT00953277     History of Changes
Other Study ID Numbers: ANG-CP-003
Study First Received: August 4, 2009
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by AxoGen, Inc:
Nerve Repair
Erectile Function
Prostate Cancer
Robot Assisted Laparoscopic Prostatectomy
Continence

Additional relevant MeSH terms:
Prostatic Neoplasms
Peripheral Nerve Injuries
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014