Balance Research
Wicab has been conducting a controlled clinical study to evaluate the safety and efficacy of the BrainPort balance device. The interim analysis of the study is currently being completed by the statisticians. Preliminary results indicate that while approximately 60% of the study participants showed improved balance, the difference between the 2 treatment groups is not statistically significant. Enrollment in the study has been closed. Wicab is investigating options moving forward. As additional information is available, it will be posted on the Wicab website.
General Clinical Trial Information
| • | Prior to beginning a clinical trial, the study is carefully reviewed and approved within each clinical site by an Institutional Review Board, which includes doctors, administrators, ethicists and members of the general public. |
| • | All volunteers for clinical trials must meet the trial inclusion and exclusion criteria and sign a consent form that describes the purpose of the trial, its duration, the procedures used, benefits and risks of the study. Volunteers may leave a clinical trial at any time without penalty. |
| • | Subject and patient confidentiality is fully protected. Patient identifying information and data collected will not be accessible outside of the clinical site without written permission by the volunteer. |
The BrainPort balance device is an Investigational Device and its use remains limited by U.S. Federal Law to investigational uses only. WICAB MAKES NO REPRESENTATIONS REGARDING THE DEVICE SAFETY OR EFFICACY.