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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Enhanced Surveillance Study

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Study Status Completed
Application Number H090002 / PAS002
Date Current Protocol Accepted 11/13/2013
Study Name Enhanced Surveillance Study
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Enhanced Surveillance Study designed to evaluate the safety of BSD-2000 Hyperthermia System. Sites will be contacted on a quarterly basis.

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 Collection Evaluation of complaints involving injury and adverse events, including acute and late toxicity associated with hyperthermia and radiotherapy treatment.

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

There are no scheduled follow-up visits for the patients. Adverse events will be captured using the Case Report Forms. The sites will be contacted quarterly for data.

Interim or Final Data Summary
Actual Number of Patients Enrolled 30
Actual Number of Sites Enrolled 7
Patient Follow-up Rate N/A. No specified follow up per protocol.
Final Safety Findings There 3 adverse events reported in 3/30 (10%) patients who received radiation + hyperthermia treatment. One AE consisted of pain due to water bolus pressure and hot spot in the vagina during treatment. One AE involved mild blisters that resolved without medical treatment, and 1 AE was determined unrelated with the hyperthermic treatment (appendicitis).

A supplemental literature review was provided to support the safety of the device. The AEs adverse events (AEs) reported in the literature included blisters, diarrhea, cystitis, skin burn, pain, nausea, anxiety, hematuria, deterioration of a decubital ulcer, ulceration, local infection from thermometry catheters, sepsis that required antiobiotic therapy, fatigue, rectal bleeding, bolus pressure and vomiting. Toxicity was reported in most studies as being similar between radio+hyperthermia treatment (RHT) and radio treatment (RT) without further specificity. One study reported a grading of 93% good and 13% moderate/severe chronic toxicity in the RHT patient group at 3 years, while another reported toxicity of 12%.
Final Effect Findings N/A, effectiveness not collected as part of this study. See H090002/PAS003 for effectiveness results of the registry study.
Study Strengths & Weaknesses The study is all-comers. Although this allows for potentially higher enrollment, the population may not reflect the same population as that of the pivotal study used to support approval of the HDE. Therefore, the safety data may not be directly comparable between the two studies. The lack of enrollment and follow up limits interpretation of the data.

Data provided from literature provide more patients for analysis, and therefore additional safety information. However, these data have important limitations. Several studies were retrospective in nature. The evidence provided from retrospective studies does not have as high quality as compared to prospective randomized controlled trials and may have confounding variables or other bias. Examples of these may include (but are not limited to): single site bias, insufficient/ incomplete patient demographic data, non-stratified patient populations, and differences in the length of follow-up. Differences in covariates can introduce biases in the assessment of the device performance, safety outcomes, and study conclusions. The standard of care and complexity of medical therapies and procedures across countries and over time may impact the conclusions from studies from different regions and time periods. Data from the literature were collected by different sources and periods of time. There is the possibility that other descriptive search terms for the device may have resulted in different publications and/or potential missed articles.
Recommendations for Labeling Changes No

Enhanced Surveillance Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/13/2014 05/14/2014 Overdue/Received
one year report 11/13/2014 11/26/2014 Overdue/Received
rqst suspend rprting-18 mon report 09/25/2015 09/25/2015 On Time
two year report 11/13/2015 03/31/2017 Overdue/Received
four year report 04/20/2018 06/25/2018 Overdue/Received
five year report 11/13/2018 11/13/2018 On Time
interim progress report 06/04/2019 06/04/2019 On Time
six year report 11/13/2019 10/31/2019 On Time
interim progress report 05/12/2020 05/12/2020 On Time
Final Report 11/13/2020 11/12/2020 On Time
seven year report 11/13/2020 11/12/2020 On Time

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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