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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


Phase 4
18 Years
70 Years
Open (Enrolling)
Male
Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Surgeon Assessment of Technical Feasibility

Outcome Time Frame:

At time of surgery

Safety Issue:

Yes

Principal Investigator

Joseph J Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt Univerisity

Authority:

United States: Institutional Review Board

Study ID:

ANG-CP-003

NCT ID:

NCT00953277

Start Date:

August 2009

Completion Date:

October 2013

Related Keywords:

  • Peripheral Nerve Injury
  • Prostate Cancer
  • Radical Prostatectomy
  • Nerve Reconstruction
  • Cavernous Nerve Injury
  • Nerve Repair
  • Erectile Function
  • Prostate Cancer
  • Robot Assisted Laparoscopic Prostatectomy
  • Continence
  • Prostatic Neoplasms

Name

Location

Vanderbilt University Nashville, Tennessee  37232-6305