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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000029 / PAS001 |
| Date Original Protocol Accepted |
09/24/2001
|
| Date Current Protocol Accepted |
09/24/2001
|
| Study Name |
Deflux Long-Term
|
| Device Name |
DEFLUX INJECTABLE GEL
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Infant: 29 days < 2 yrs,
Child: 2 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is an open, non-randomized, multi-center study in 149 children older than 1 year of age using new data collection.
|
| Study Population |
Study population is as per device indication: This device is indicated for treatment of children with vesicoureterarle flux (VUR) grades1 11-IVW
|
| Sample Size |
The sample size is 149 patients using Deflux. There will be approximately 10-15 sites with each center having approximately 15 patients.
|
| Key Study Endpoints |
The primary outcome is grade of reflux according to the VCUG at 3 months after last treatment. The grading is performed by a non-treating physician. Secondary efficacy variable is absence of febrile UTI. There will be 8 visits, including screening, baseline, 3 months, 12 months and once annually for years 2-5. Subjects will be seen by a physician at these time points
|
| Follow-up Visits and Length of Follow-up |
There are 6 scheduled follow up visits after the treatment visit. The length of follow up is 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
165 Subjects
|
| Actual Number of Sites Enrolled |
12 Sites
|
| Patient Follow-up Rate |
18.8% (31/165)
|
| Final Safety Findings |
Treatment-emergent adverse events were experienced by 60% of subjects with most events rated as mild or moderate in intensity. The most common TEAEs were urinary tract infection (18%) and micturition urgency (12%). 12% of subjects experienced TEAEs related to the injection or device and 7% experienced a serious TEAE.
|
| Final Effect Findings |
Success rate for the primary effectiveness endpoint (Vesico Ureteral Reflux grade at UCUG at 3 months after Deflux treatment) was 66.1% (95% CI 58.3% to 73.2%).
|
| Study Strengths & Weaknesses |
Strengths of this study include a prospective design of adequate sample size for evaluation of the short-term (3-month) primary effectiveness endpoint. The main limitation is the low 5-year follow-up rate of 18.8%. However, evaluation of longer-term safety was addressed in an extensive systematic review of the available literature.
|
| Recommendations for Labeling Changes |
Labeling changes are recommended based on the safety and effectiveness results of the post- approval study and the longer-term safety of Deflux described in the systematic literature review.
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