The Menlo Park, Calif.-based company’s device is designed to deliver mometasone furoate directly to a person’s sinuses at the time of dilation.
The 70-person study is slated to explore whether the Ascend device can reduce inflammation by delivering a steroid directly to the dilated tissue while opening passages in the sinuses.
The trial’s primary endpoint, which will be evaluated after 30 days, will include the device’s ability to improve patency rates.
In the study, Intersect’s Ascend device will be randomized against an uncoated balloon. The company expects to report topline results by the end of 2019.
“We are excited to begin enrollment in this study of our fifth product leveraging our expertise in localized drug delivery, and we believe that this product, if approved, would be complementary to our current product offerings,” president & CEO Lisa Earnhardt said in prepared remarks. “This is an important milestone for Intersect ENT, and illustrates our continued commitment to developing innovative solutions for sinus patients.”
“The Ascend study will aim to assess the potential benefits of directed drug delivery at the time of balloon dilation, a potential advance beyond the current treatment paradigm,” principal investigator Dr. Boris Karanfilov added.