|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
H090002 / PAS003 |
| Date Original Protocol Accepted |
11/18/2011
|
| Date Current Protocol Accepted |
11/13/2013
|
| Study Name |
Registry Study
|
| Device Name |
BSD-2000 HYPERTHERMIA SYSTEM
|
| 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 Objectives |
All-comers registry study
|
| Study Population |
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.
|
| Key Study Endpoints |
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.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
24
|
| Actual Number of Sites Enrolled |
5
|
| Patient Follow-up Rate |
3 months: 9/24 (38%)
12 months: 1/24 (4.2%)
18 months: 0/24 (0%)
24 months: 0/24 (0%)
36 months: 0/24 (0%)
|
| Final Safety Findings |
There 2 adverse events reported in 2/24 (8.3%) patients who received radiation + hyperthermia treatment. One AE consisted of mild blisters that resolved without medical treatment, and 1 AE was determined unrelated with the hyperthermic treatment (appendicitis).
|
| Final Effect Findings |
There were two patient reports of tumor volume reduction. In one patient, tumor dimensions were reduced from W 3.5cm to 1.8cm and L 2.6 cm to
1.5cm. In another patient, tumor dimensions went from 4.5cm to 1.8cm.
|
| Study Strengths & Weaknesses |
The registry 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 and effectiveness 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 and effectiveness 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
|
