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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)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01054534
Enrollment
1
Registered
2010-01-22
Start date
2010-07-31
Completion date
2012-12-31
Last updated
2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

urinary incontinence

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.

Interventions

PROCEDUREPlacement of interstim lead

Placement of insterstim lead using US image fusion technology

Sponsors

Medtronic
CollaboratorINDUSTRY
Traxtal
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patient consented for Interstim lead placement

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Identify the third sacral foramen of the pelvis through US image fusion technologyat time of procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026