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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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Registry Study

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Study Status Progress Inadequate
Application Number H090002 / PAS003
Date Current Protocol Accepted 11/13/2013
Study Name Registry Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description All-comers registry study
Study Population Description Patients with cervical cancer treated with BSD-2000. Patients who

have had or not had prior irradiation of the treatment site also will be included. Patients who have had chemotherapy administered also will be included.

Sample Size No specified sample size or number of clinical sites. Data will be

collected on all patients who are treated with the device and agree to participate in the study.

Data Collection Primary endpoint:

-Rate of complete response (CR), defined as the disappearance of all viable tumor in the irradiated volume.

- Local tumor control and duration of local tumor control

Secondary endpoints:

- Overall survival (defined as death from any cause) at 3 years

- Disease free survival

- Incidence of adverse events associated with hyperthermia and radiotherapy treatment.

Follow-up Visits and Length of Follow-up Up to 3 years.

Follow-up examinations will be performed at 3, 12, 18, 24 and 36 months intervals.

Registry Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
annual report 11/19/2013 11/19/2013 On Time
six month report 05/13/2014 05/14/2014 Overdue/Received
one year report 11/13/2014 11/26/2014 Overdue/Received
18 month report 06/13/2015 11/23/2015 Overdue/Received
two year report 11/13/2015 04/06/2017 Overdue/Received
four year report 04/20/2018 04/23/2018 Overdue/Received
five year report 10/15/2018 10/09/2018 On Time
six year report-final 11/13/2019 09/17/2020 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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