Nerve Access Tool Study

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942474

Enrollment

Registered

2009-07-21

Start date

2009-10-31

Completion date

2010-03-31

Last updated

2014-02-19

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

Conditions

Cystocele

Keywords

The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement

Brief summary

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

Interventions

DEVICEFacilitate nerve stimulation lead placement with the nerve access tool

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Electromyography Response	Implant

Outcome results

None listed

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