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STUDY DESIGN This study is a placebo-controlled, randomized, double-blind parallel group design. PROCEDURE GROUPS There will be two procedure groups in this study, with an equal number of subjects assigned to each of the two groups, as follows: Test group: Subjects in the test group will receive the actual procedure with the Resonator™ device activated. Placebo (control) group: Subjects in the placebo group will receive a ‘sham’ procedure with the Resonator™ device not activated. Apart from the distinction of whether or not the subject receives procedures with the Resonator™ device activated, all subjects and the investigative parties will adhere to all phases of the entire protocol design. SUBJECT PROCEDURE GROUP RANDOMIZATION Upon study qualification, subjects will be randomized to one of the two procedure groups via a randomized block design with varying block sizes of two and four subjects. In each block, one-half of the subjects will be randomly assigned to each of Procedure Groups A and B. Randomization will be attained using computer generation sequence methodology, insuring that the randomization methodology and the generated allocation sequence is concealed from the investigator and subjects. Concealment will be insured as follows:
Once a subject has qualified for and enrolled in the study, the PI will contact the study Monitor who will act as the central source for providing sequential subject group assignment. |
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The Resonator™ device is an Investigational Device limited by Federal (or United States) |
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