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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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Newly Enrolled

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522 Number / Requirement Number PS130041 / PSS001
Current Plan Approved 08/07/2015
Study Name Newly Enrolled
Root Document Number K121858 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The manufacturer will address the postmarket surveillance (522) order using data from a larger study that they are conducting (the Treatment Results of Uterine Sparing Technologies Study, "TRUST"). The study is designed as a postmarket, randomized, prospective, multi-center, longitudinal, comparative study, to compare the direct and indirect cost of three treatments for symptomatic uterine fibroids (GFA, myomectomy, and uterine artery embolization). However, the study also includes data collection for endpoints that will address the questions in the postmarket surveillance (522) study order: the rates of acute and near-term serious complications in the global fibroid ablation (GFA) subjects (groups combined) will be compared to the acute and near-term treatment-related serious adverse event rates of the pivotal (premarket) study (Historical Control).

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 in up to 6 sites in the US

Data Collection "Primary Endpoints:

¿ 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:

¿ Incidence of serious complications per investigator-surgeon during training and post training.

¿ 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.

Newly Enrolled Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/29/2014 08/21/2014 On Time
1 yr report 02/28/2015 02/27/2015 On Time
18 month report 08/29/2015 08/31/2015 Overdue/Received
2 yr report 02/28/2016 02/26/2016 On Time
3 yr report 02/27/2017    
4 yr report 02/27/2018    
5 yr report 02/27/2019    

  • 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.


Contact Information

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

Phone: (301) 796-7033
Fax: (301) 847-8140