|
General |
Study Status |
Other |
Application Number / Requirement Number |
P060017 / PAS002 |
Date Original Protocol Accepted |
10/29/2007
|
Date Current Protocol Accepted |
10/29/2007
|
Study Name |
TS Study
|
Device Name |
GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
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General Study Protocol Parameters |
Study Design |
Cross-Sectional Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The post-approval study is designed to address the following objectives: 1) to determine, under clinical use conditions, the assay turn-around-time from the time of node removal to the report of the assay result to the surgeon, 2) to determine, under clinical use conditions, whether the assay result was or was not received in time to make an intra-operative decision, and 3) to collect data in relation to other surgical procedures during the sentinel lymph node dissection/breast surgery to determine if the assay turn arround time resulted in longer surgery time than would have occurred if the assay had not been used.
|
Study Population |
Study Population: Breast cancer patients. Indication: The device is indicated as an in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodul tissue removed from the sentinel lymph nodes biopsies of breast cancer patients.
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Sample Size |
320 patients, 4 sites
|
Key Study Endpoints |
Assay turn-around-time data was collected on each eligible patient from the time the sentinel lymph node(s) were excised from the patient until the patient assay result was reported back to the surgeon. The relationship to other surgical procedures during the sentinel lymph node dissection/breast surgery will be collected to determine if the assay turn-around-time resulted in longer surgery time than would have occurred if the assay had not been used.
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Follow-up Visits and Length of Follow-up |
Follow-up was not required for this study.
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