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NCT00942474 Clinical Trial

Nerve Access Tool Study

Cystocele Clinical Trial

Official title:
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00942474
Other study ID # #1632
Secondary ID
Status Withdrawn
Phase N/A
First received July 20, 2009
Last updated February 18, 2014
Start date October 2009
Est. completion date March 2010

Study information
Verified date February 2014
Source MedtronicNeuro
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.

Recruitment information / eligibility
Status Withdrawn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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• Facilitate nerve stimulation lead placement with the nerve access tool

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
MedtronicNeuro

Outcome
Type Measure Description Time frame Safety issue
Primary Electromyography Response Implant No
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