US-based Intersect ENT has commenced a blinded, multi-centre, prospective, randomised clinical study of its new steroid delivery implant for treating patients with recurrent sinus obstruction.
The implant, which is placed during a routine physician office visit, releases mometasone furoate steroid into the lining of the sinus to dilate the re-obstructed sinus and resolve inflammation.
The device, which has more radial strength than the PROPEL and PROPEL mini dissolvable steroid-releasing implants, releases the steroid over a longer period of time and improves sinus surgery outcomes, according to the company.
The trial, RESOLVE, will enrol 100 patients to evaluate the safety and effectiveness of implant in patients with polyps, which recur in up to 60% of patients following endoscopic sinus surgery and are the leading cause for revision surgery.
Louisville-based Advanced ENT & Allergy's practicing otolaryngology doctor Keith Forwith and Eastern Virginia Medical School's rhinology and endoscopic sinus/skull base surgery director Joseph Han will act as co-principal investigators for the study.
Intermountain ear, nose and throat specialists Steven Miller said: "This novel in-office treatment promises to become an important treatment alternative to aggressive oral steroid therapy or revision sinus surgery for chronic sinusitis patients."
Intersect ENT president and CEO Lisa Earnhardt said: "The reception from the physician community to localised steroid delivery and our PROPEL family of implants has been extraordinary, and we're proud to be partnering with leading clinicians on RESOLVE to further expand the treatment options for sinus sufferers."