Nerve Access Tool Study

Medtronic

Status: Withdrawn

Conditions: Cystocele

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942474

#1632

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Research Arm

Experimental group

Description:

Facilitate nerve stimulation lead placement with the nerve access tool

Treatment:

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