Trial Testing Radio Waves to Clear Nasal Blockages

Bradley Otto views computer scans of air flow through nasal passages (Ohio State University)

14 May 2018. A small-scale clinical trial is recruiting participants to test radio signals for clearing nasal passages obstructed by deformed soft tissue, instead of drugs or surgery used today in many cases. The study, conducted at Ohio State University, is evaluating a device made by medical device developer and funder of the trial, Aerin Medical Inc. in Sunnyvale, California.

Aerin Medical is the maker of Vivaer nasal airway remodeling system to treat obstructions in in the nasal valve area, the narrowest part of nasal passage. Obstruction of nasal passages is a common condition, and one of the more frequent disorders treated by ear, nose, and throat specialists. Nasal passages can become blocked due to allergies or dust irritation, but also by deformities in the septum, the cartilage structure in the nose separating the nostrils. These structural problems sometimes require surgery to correct, with some 600,000 new cases diagnosed in the U.S. each year, according to the company.

The Vivaer system, says Aerin Medical, uses radio-frequency waves to reshape deformed nasal  passage tissue. The company says its algorithms determine the optimum concentrated electronic signals, without high temperatures or destroying or removing the tissue. The treatments are delivered with a stylus inserted in the nose to shrink soft tissue below the mucous layers, including cartilage blocking the nasal passages. Vivaer therapies, says Aerin, are designed for administration in a doctor’s office with a local anesthetic in about 15 minutes.

The clinical trial is enrolling 15 adults who say they experienced nasal obstructions for at least a year. Participants for the study are also those who experienced temporary relief with nasal dilator strips or stents, or who can open their nasal passages by gently pulling on either side of the nose. All individuals receive Vivaer treatments; there is no comparison or placebo group. All participants are rated before and 90 days after the treatments with a self-evaluated nasal obstruction symptom evaluation, or NOSE, scale and a visual scale of nasal obstruction. Individuals will also be evaluated with CT scans and other measures.

Bradley Otto, a professor of otolaryngology — ear, nose, and throat medicine — at Ohio State is leading the study. “What this technology does,” says Otto in a university statement, “is reshape the internal nasal valve region, which is a region where cartilage on the side of your nose meets your septum. Basically what it causes the cartilage to do is barely denature and change its shape just a little bit in order to open up that valve and improve airflow to that region.”

In the following video, Otto and a patient with nasal obstructions tell more about the treatments.

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