Bariatric Medical Institute of Texas Presents Favorable Study Results for Obalon Balloon Administration Using Navigation Device and Touch Dispenser
The co-primary endpoints of the Continuous Obalon Balloon Administration Location Tracking (COBALT) Study were met, with 100% correct decision-making for administering and inflating the Obalon Balloon System using the Navigation device instead of X-ray imaging. The study data also demonstrated 100% agreement between the Navigation System assessments and x-ray images collected but not used to make any decision to initiate inflation. There were no serious adverse events observed in the study and the overall adverse event rate was 3.9% with none of the events relating to the Navigation System or Touch Dispenser.
“These results suggest that the Navigation device can be used to safely and accurately administer Obalon Balloons without the use of radiography,” said Dr. Seger. “Prior studies support the ability to achieve safe and effective weight loss with the Obalon Balloon System, and the use of Navigation can remove a key barrier to balloon administration when X-ray imaging is not accessible.”
The Obalon Navigation System provides treating physicians with the ability to place the Obalon Balloon without having to incur the costs and inconvenience of utilizing x-ray imaging. The Obalon Navigation System is a portable, easy to use, non-invasive, radiation free, self-contained imaging system that is
“These data demonstrate the robustness of our Navigation System, which like our gastric balloon, continues to perform well in clinical studies and in commercial use,” said
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Source: Obalon Therapeutics, Inc.