Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

Not Applicable

Terminated

• Conditions: Urinary Incontinence
• Interventions: Procedure: Placement of interstim lead

• Registration Number: NCT01054534
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Study Start: 2010-07
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Patient consented for Interstim lead placement

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Exclusion Criteria

• Patients requesting not to be in the study.
• Pregnant patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placement of interstim lead	Placement of interstim lead	Placement of interstim lead using US image fusion technology

Primary Outcome Measures

Name	Time	Method
Identify the third sacral foramen of the pelvis through US image fusion technology	at time of procedure

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States