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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

(IDE) Long Term Follow-up


 
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General
Study Status Completed
522 Number / Requirement Number PS130041 / PSS002
Date Current Plan Accepted 12/09/2013
Study Name (IDE) Long Term Follow-up
Root Document Number K121858 
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a post-market, randomized, prospective, multi-center, longitudinal, comparative study to compare the rates of acute and near-term serious complications in the global fibroid ablation (GFA) subjects (groups combined) to the acute and near-term treatment-related serious adverse event rates of the pivotal (pre-market) study. The 522 order questions above are being addressed as endpoints in a larger study being conducted by the sponsor (the Treatment Results of Uterine Sparing Technologies Study, or ¿TRUST¿).

Study Population Description Premenopausal female patients >/= 18 years old who have symptomatic fibroids, who desire uterine conservation, and who are indicated for a surgical intervention for their symptoms.

Sample Size 100 subjects will be enrolled at up to 6 clinical sites within the United States

Data Collection Primary Endpoints: 1.Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related SAE rates in the pivotal study. Secondary Endpoints: 1. Incidence of serious complications per investigator-surgeon during training and post training. 2. Investigator/surgeon feedback using the Acessa¿ Procedure Evaluation Form.

Follow-up Visits and Length of Follow-up Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure, and office or phone follow-up visits at 4-8 weeks post treatment. Telephone follow up will occur at 24 to 72 hours post treatment.

Interim or Final Data Summary
Final Safety Findings The 522 order was fufilled by the IDE final report. The Investigational Device Exemption Reports are considered to be confidential and therefore not releasable.


(IDE) Long Term Follow-up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 08/01/2014 07/17/2014 On Time


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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