REMODEL – A Landmark Study
- Posted on: Apr 10 2013
Dr. James Gould of the St. Louis Sinus Center is changing the way sinusitis is treated by dramatically and instantly improving lives with an in-office procedure. This innovation in the treatment of debilitating sinusitis symptoms is called XprESS Balloon Sinus Dilation. The non-surgical procedure is so simple and quick it can be done in the physician’s office under local anesthesia.
Dr. Gould was a principal study investigator for a groundbreaking study called REMODEL. The study was designed to measure the comparative results of traditional functional sinus surgery (FESS) to the balloon sinus dilation procedure in patients with uncomplicated chronic sinusitis. This study is the first prospective, multi-center, randomized, controlled trial with sufficient statistical power to compare the two types of treatments.
Traditional functional sinus surgery (FESS) involves cutting and removal of tissue to open narrowed sinus drainage pathways whereas balloon sinus dilation preserves sinus tissue by opening the drainage pathways with a balloon that is temporarily inserted into the nose, inflated for a few seconds, deflated and then removed.
The result of the study proves patients experience significant sinus symptom improvement with balloon sinus dilation that is as effective and durable as traditional functional sinus surgery (FESS.) Furthermore, the study showed that standalone balloon sinus dilation offered significant advantages compared to FESS, which include:
- Less postoperative bleeding.
- Fewer follow-up procedures (debridements.)
- Less duration of prescription pain medication use.
- Faster recover time.
- Quicker short-term improvement.
The statistical evidence found in the REMODEL study reflects what Dr. Gould sees everyday with his patients at the St. Louis Sinus Center. In addition, Dr. Gould finds many more important benefits, such as:
- Patient convenience with having the procedure performed in the office versus the hospital or surgery center.
- Local versus general anesthesia
- Lower procedural costs for the patient and the overall healthcare system (since performed in the office versus surgery center or hospital.)
Dr. Gould is thrilled to see this pivotal study presented to the world’s literature.
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