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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ODE Lead-Long Term PAS


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General
Study Status Progress Adequate
Application Number P150038 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Long-term prospective, observational clinical trial to follow device related safety, and long term effectiveness and quality of life for subjects previously treated with the ExAblate Neuro under the IDE G120246.
Study Population Description The study population includes those patient that have undergone the ExAblate Neuro thalamotomy treatment for the treatment of medication refractory Essential Tremor under G120246.

Sample Size There are three main cohorts from the original pivotal study that will be included in this long term follow-up study:

1. The main IDE (G120246) study population that was randomized, N=56.

2. The cross-over population, N=21

3. The population that was part of the Continued Access study, N=59
Data Collection Safety: Safety of ExAblate will be determined by an evaluation of the incidence and severity of device / treatment related complications from the treatment day visit through ALL study follow ups through Year 5. Adverse events (type, frequency, severity) are expected to be similar to those of previous studies using ExAblate TcMRgFUS for Thalamotomy

Effectiveness: Primary effectiveness will be assessed using the Clinical Rating Scale for Tremor (CRST) as scored by the site neurologist. Secondary effectiveness will be assessed by using the Quality of Life inn Essential Tremor (QUEST) Questionnaire.

Follow-up Visits and Length of Follow-up 5 years


ODE Lead-Long Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2017 03/03/2017 Overdue/Received
one year report 07/11/2017 08/11/2017 Overdue/Received
18 month report 01/09/2018    
two year report 07/11/2018    
three year report 07/11/2019    
four year report 07/10/2020    
five year report 07/10/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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