Cystocele Clinical Trial
Official title:
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
Verified date | February 2014 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electromyography Response | Implant | No |
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