Ultrasound Image Fusion for Placement of Sacral Quadripol... | NCT01054534

Studies
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

NCT01054534

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Apr 13, 2015Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Urinary Incontinence

Interventions

Placement of interstim lead

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor withdrew funding

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 20, 2010

First Submission Date that Met QC Criteria

Jan 21, 2010

First Posted Date

Jan 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Name	Class
Medtronic	INDUSTRY
Traxtal	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placement of interstim lead	Other	Placement of interstim lead using US image fusion technology	Procedure: Placement of interstim lead

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of interstim lead	Procedure	Placement of insterstim lead using US image fusion technology	Placement of interstim lead

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the third sacral foramen of the pelvis through US image fusion technology		at time of procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient consented for Interstim lead placement

Exclusion Criteria:

Patients requesting not to be in the study.
Pregnant patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Clendenen, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32224	United States

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided