Right now, ear, nose and throat (ENT) specialists throughout the U.S. are taking part in the REMODEL Clinical Study. If you suffer from chronic sinus infections, and have not received lasting relief through medications, this study may be right for you. The REMODEL study is comparing two procedures for chronic sinusitis, both of which are designed to improve sinus drainage and provide long-term relief of sinusitis symptoms:

Functional Endoscopic Sinus Surgery (FESS)
Functional endoscopic sinus surgery is a surgical procedure used by ENT specialists to improve sinus drainage by enlarging the drainage pathways. This is done using specialized instruments to remove nasal obstructions and expand the sinus ostia, the natural opening of the sinus. Traditional sinus surgery is an outpatient procedure, with patients returning home the same day.

Balloon Sinus Dilation
Balloon sinus dilation is a minimally-invasive procedure used by ENT specialists to reshape sinus anatomy by inflating small balloons in key places in the nose and sinus to expand sinus pathways and restore drainage. Balloon sinus dilation is performed under local anesthesia on an outpatient basis, with patients returning home the same day.

Participating in the REMODEL Study

If you qualify and choose to participate in the REMODEL study, your sinusitis will be treated by a local ENT specialist using one of two procedures: Functional Endoscopic Sinus Surgery (FESS), or Balloon Sinus Dilation. Both of these procedures are designed to improve sinus drainage and provide long-term relief of sinusitis symptoms. The decision as to which treatment you will receive is decided at random, like picking a number from a hat. As part of the study, you will have a 50/50 chance of receiving either procedure for your sinusitis.

Following your procedure, you will be asked to visit your doctor’s office at regular intervals over a 2-year period (approximately 7 total visits). These visits allow your doctor to closely monitor your sinusitis symptoms and condition. During these visits, you will be asked about your experiences, and will also complete questionnaires and tests to track your individual results. As a REMODEL study participant, you will be compensated for your time and travel.

All studies, including this one, involve some risks (complications or side effects from
the study treatment). Prior to joining this study, your doctor will discuss the risks
and potential benefits with you in detail to help you decide whether the study may be right for you.