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NCT01054534 Clinical Trial

Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

Urinary Incontinence Clinical Trial

Official title:
Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01054534
Other study ID # 09-000293
Secondary ID
Status Terminated
Phase N/A
First received January 20, 2010
Last updated April 10, 2015
Start date July 2010
Est. completion date December 2012

Study information
Verified date April 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

- Patient consented for Interstim lead placement

Exclusion Criteria:

- Patients requesting not to be in the study.

- Pregnant patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• Placement of interstim lead
Placement of insterstim lead using US image fusion technology

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (3)
Lead Sponsor Collaborator
Mayo Clinic Medtronic, Traxtal

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify the third sacral foramen of the pelvis through US image fusion technology at time of procedure No
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