Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

NCT ID: NCT01054534

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Placement of interstim lead

Placement of interstim lead using US image fusion technology

Group Type OTHER

Placement of interstim lead

Intervention Type PROCEDURE

Placement of insterstim lead using US image fusion technology

Interventions

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Placement of interstim lead

Placement of insterstim lead using US image fusion technology

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient consented for Interstim lead placement

Exclusion Criteria

* Patients requesting not to be in the study.
* Pregnant patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Traxtal

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Steven R. Clendenen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Clendenen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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09-000293

Identifier Type: -

Identifier Source: org_study_id

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