Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report
During the study whenever you have an arm volume measurement using the Perometer, we will
also measure the fluid in your arms using Bioimpedance Spectroscopy. These measurements are
made by passing a harmless electrical signal of very low strength through your body to
determine the difference in the amount of fluid in each arm. The test is simple and
painless, and takes about 3 minutes. In addition, whenever you have an arm measurement, you
will be asked to complete a questionnaire. While completing the questionnaire, you can skip
any questions you do not wish to answer. The questionnaires will take about 10 minutes to
complete. Arm measurements with the Perometer and Bioimpedance Spectroscopy and completion
of the questionnaire will occur every 4-7 months when you are at MGH for regular medical
visits.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Correlation of impedance ratios obtained through bioimpedance spectroscopy (BIS)with perometric relative arm volume change (RVC) and self-reported symptom data
Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated inthe LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with imepdance ratios calculated using the BIS device software.
5 years
No
United States: Institutional Review Board
11-325
NCT01544335
December 2011
Name | Location |
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Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |