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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2009

Last Updated Date

March 4, 2013

Start Date ^ICMJE

August 2009

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00953277 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Other: Processed Human Nerve Tissue Scaffold

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

Study Arm (s)

Experimental: Avance Nerve Graft

Processed Human Nerve Tissue Scaffold

Intervention: Other: Processed Human Nerve Tissue Scaffold

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00953277

Other Study ID Numbers ^ICMJE

ANG-CP-003

Has Data Monitoring Committee

Responsible Party

AxoGen, Inc

Study Sponsor ^ICMJE

AxoGen, Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joseph J Smith, MD

Vanderbilt Univerisity

Information Provided By

AxoGen, Inc

Verification Date

March 2013

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

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