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
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: 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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014