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Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

This study has been terminated.
(Sponsor withdrew funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054534
First Posted: January 22, 2010
Last Update Posted: April 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic
Traxtal
Information provided by (Responsible Party):
Steven R. Clendenen, Mayo Clinic
  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: None (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 Steven R. Clendenen, Mayo Clinic:

Primary Outcome Measures:
  • Identify the third sacral foramen of the pelvis through US image fusion technology [ Time Frame: at time of procedure ]

Enrollment: 1
Study Start Date: July 2010
Study Completion Date: December 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Steven R. Clendenen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01054534     History of Changes
Other Study ID Numbers: 09-000293
First Submitted: January 20, 2010
First Posted: January 22, 2010
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Steven R. Clendenen, Mayo Clinic:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders