Back to resultsNerve Access Tool Study
Primary Purpose
Cystocele
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Facilitate nerve stimulation lead placement with the nerve access tool
Sponsored by
About this trial
This is an interventional basic science trial for Cystocele focused on measuring The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
Eligibility Criteria
Inclusion Criteria:
- Subject is equal to or greater than 18 years of age
- Subject has a diagnosis of cystocele with planned surgical repair
- Subject has no known deficit of the nerve
- Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
- Subject is willing and able to comply with the study protocol
Exclusion Criteria:
- Subject has known neurological abnormalities of the nerve
- Subject has a known allergy to the tool or neurostimulation lead components
- Subject is pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Research Arm
Arm Description
Facilitate nerve stimulation lead placement with the nerve access tool
Outcomes
Primary Outcome Measures
Electromyography Response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00942474
Brief Title
Nerve Access Tool Study
Official Title
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Medtronic made a business decision to discontinue the study and withdraw the IDE.
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele
Keywords
The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Research Arm
Arm Type
Experimental
Arm Description
Facilitate nerve stimulation lead placement with the nerve access tool
Intervention Type
Device
Intervention Name(s)
Facilitate nerve stimulation lead placement with the nerve access tool
Primary Outcome Measure Information:
Title
Electromyography Response
Time Frame
Implant
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is equal to or greater than 18 years of age
Subject has a diagnosis of cystocele with planned surgical repair
Subject has no known deficit of the nerve
Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
Subject is willing and able to comply with the study protocol
Exclusion Criteria:
Subject has known neurological abnormalities of the nerve
Subject has a known allergy to the tool or neurostimulation lead components
Subject is pregnant or lactating
12. IPD Sharing Statement
Learn more about this trial
Nerve Access Tool Study
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