- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942474
Nerve Access Tool Study
February 18, 2014 updated by: MedtronicNeuro
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Research Arm
Facilitate nerve stimulation lead placement with the nerve access tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electromyography Response
Time Frame: Implant
|
Implant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
July 20, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (Estimate)
July 21, 2009
Study Record Updates
Last Update Posted (Estimate)
February 19, 2014
Last Update Submitted That Met QC Criteria
February 18, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #1632
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystocele
-
Medical University of ViennaRecruitingPelvic Organ Prolapse | Cystocele | Vaginal Prolapse | Cystocele, Midline | Prolaps BladderAustria
-
Zagazig UniversityCompletedProlapse, Vaginal | Paravaginal Cystocele
-
National Taiwan University HospitalCompletedLower Urinary Tract Symptom in Severe Cystocele Women
-
Charles University, Czech RepublicRecruitingPelvic Organ Prolapse | Cystocele | Cystocele and Incomplete Uterovaginal ProlapseCzechia, Slovakia
-
Karolinska InstitutetStockholm County Council, Karolinska Institutet research foundations, Swedish...CompletedSurgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
-
National Taiwan University HospitalCompletedUrodynamic Stress Incontinence in Severe Cystocele Women
-
The Cleveland ClinicCompletedPelvic Organ Prolapse
-
Atrium Medical CenterMaastricht UniversityUnknown
-
Mount Sinai Hospital, CanadaCompleted
-
Ain Shams Maternity HospitalCompleted
Clinical Trials on Facilitate nerve stimulation lead placement with the nerve access tool
-
University of California, San DiegoThe Cleveland Clinic; Augusta University; United States Naval Medical Center,... and other collaboratorsCompletedRotator Cuff Repair | Anterior Cruciate Ligament Reconstruction | Ankle Arthrodesis or Arthroplasty | Hallux Valgus CorrectionUnited States
-
SetPoint Medical CorporationActive, not recruitingRheumatoid ArthritisUnited States
-
Attikon HospitalUnknownPostoperative Pain | Anterior Cruciate Ligament ReconstructionGreece, Italy