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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
January 20, 2010
January 22, 2010
April 13, 2015
July 2010
December 2011   (Final data collection date for primary outcome measure)
Identify the third sacral foramen of the pelvis through US image fusion technology [ Time Frame: at time of procedure ]
Same as current
Complete list of historical versions of study NCT01054534 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Urinary Incontinence
Procedure: Placement of interstim lead
Placement of insterstim lead using US image fusion technology
Placement of interstim lead
Placement of interstim lead using US image fusion technology
Intervention: Procedure: Placement of interstim lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient consented for Interstim lead placement

Exclusion Criteria:

  • Patients requesting not to be in the study.
  • Pregnant patients
Sexes Eligible for Study: Female
30 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01054534
09-000293
No
Not Provided
Not Provided
Steven R. Clendenen, Mayo Clinic
Mayo Clinic
  • Medtronic
  • Traxtal
Principal Investigator: Steven Clendenen, MD Mayo Clinic
Mayo Clinic
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP