Use of Mometasone Eluting Stent in Choanal Atresia

Objective: To determine the utility of mometasone eluting stents in the treatment of choanal
atresia.

Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric
Otolaryngology, Head and Neck Surgery

Study Design: Randomized, single blind control trial

Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion
criteria will include all subjects less than 11 years of age who are diagnosed with either
unilateral or bilateral choanal atresia. Following enrollment, the patients will be
randomized to either a control arm (no stent) versus an intervention arm (placement of drug
eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either
no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be
performed to assess size which will be reviewed and graded by two independent reviewers.

Analysis: Descriptive statistical analysis and multivariate analysis will be performed.

Inclusion Criteria:

- Subjects who are under 11 years old and have a diagnosis of choanal atresia will be
included in this study.

Exclusion Criteria:

- Those subjects who are 11 years of age or greater or who do not have choanal atresia
will be excluded.