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CompletedNCT00953277Updated Aug 12, 2024

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

A Phase 4 interventional study of Processed Human Nerve Tissue Scaffold in Peripheral Nerve Injury, Prostate Cancer and Radical Prostatectomy, sponsored by Axogen Corporation. Completed at 1 site in United States. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Axogen Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

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

Keywords

  • Nerve Repair
  • Erectile Function
  • Prostate Cancer
  • Robot Assisted Laparoscopic Prostatectomy
  • Continence
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Axogen Corporation is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Avance Nerve Graft

    Processed Human Nerve Tissue Scaffold

    Other: Processed Human Nerve Tissue Scaffold

Interventions

  • OtherProcessed Human Nerve Tissue Scaffold

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

06

What researchers measure

Primary outcomes

  1. Surgeon Assessment of Technical Feasibility

    Time frame: At time of surgery

Secondary outcomes

  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

07

Study locations

1 site
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00953277
Lead sponsor
Axogen Corporation
Responsible party
Sponsor
First posted
Aug 6, 2009
Start date
Aug 2009
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Aug 12, 2024

Study contacts

Joseph J Smith, MD
principal investigator · Vanderbilt Univerisity

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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