In January 2005, the oversight responsibility of the Post-Approval 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).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 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 PAS 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 PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
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.
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.
Followup Visits and Length of Followup
Up to 3 years. Follow-up examinations will be performed at 3, 12, 18, 24 and 36