Back to resultsUltrasound Image Fusion for Placement of Sacral Quadripolar Leads
Primary Purpose
Urinary Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement of interstim lead
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence focused on measuring urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Patient consented for Interstim lead placement
Exclusion Criteria:
- Patients requesting not to be in the study.
- Pregnant patients
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Placement of interstim lead
Arm Description
Placement of interstim lead using US image fusion technology
Outcomes
Primary Outcome Measures
Identify the third sacral foramen of the pelvis through US image fusion technology
Secondary Outcome Measures
Full Information
NCT ID
NCT01054534
First Posted
January 20, 2010
Last Updated
April 10, 2015
Sponsor
Mayo Clinic
Collaborators
Medtronic, Traxtal
1. Study Identification
Unique Protocol Identification Number
NCT01054534
Brief Title
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
Official Title
Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew funding
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Medtronic, Traxtal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placement of interstim lead
Arm Type
Other
Arm Description
Placement of interstim lead using US image fusion technology
Intervention Type
Procedure
Intervention Name(s)
Placement of interstim lead
Intervention Description
Placement of insterstim lead using US image fusion technology
Primary Outcome Measure Information:
Title
Identify the third sacral foramen of the pelvis through US image fusion technology
Time Frame
at time of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient consented for Interstim lead placement
Exclusion Criteria:
Patients requesting not to be in the study.
Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Clendenen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
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