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Nerve Access Tool Study

This study has been terminated.
(Medtronic made a business decision to discontinue the study and withdraw the IDE.)
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00942474
First received: July 20, 2009
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention
Cystocele
 Procedure: Facilitate nerve stimulation lead placement with the nerve access tool

Study Type: Interventional
Study Design: Masking: Open Label
Official Title: A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool

Further study details as provided by MedtronicNeuro:

Estimated Enrollment: 11
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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/HIPAA 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942474

Locations
United States, Minnesota
Metro Urology
Woodbury, Minnesota, United States, 55125
Sponsors and Collaborators
MedtronicNeuro
  More Information

No publications provided

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00942474     History of Changes
Other Study ID Numbers: #1632
Study First Received: July 20, 2009
Last Updated: June 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement

Additional relevant MeSH terms:
Cystocele
Urinary Bladder Diseases
Urologic Diseases
 Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013