Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

This study has been terminated.
Sponsor:
Collaborators:
Medtronic
Traxtal
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01054534
First received: January 20, 2010
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.


Condition Intervention
Urinary Incontinence
Procedure: Placement of interstim lead

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Identify the third sacral foramen of the pelvis through US image fusion technology [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placement of interstim lead
Placement of interstim lead using US image fusion technology
Procedure: Placement of interstim lead
Placement of insterstim lead using US image fusion technology

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient consented for Interstim lead placement

Exclusion Criteria:

  • Patients requesting not to be in the study.
  • Pregnant patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054534

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Medtronic
Traxtal
Investigators
Principal Investigator: Steven Clendenen, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Steven Clendenen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01054534     History of Changes
Other Study ID Numbers: 09-000293
Study First Received: January 20, 2010
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014