Clinical trial NCT03605537: Use of Mometasone Eluting Stent in Choanal Atresia
Official title: Use of Mometasone Eluting Stent in Choanal Atresia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Choanal Atresia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 0
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Posterior Nasal Cavity
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: CCHMC
name: Catherine Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deutsch E, Kaufman M, Eilon A. Transnasal endoscopic management of choanal atresia. Int J Pediatr Otorhinolaryngol. 1997 May 4;40(1):19-26. doi: 10.1016/s0165-5876(96)01486-3.
citation: Strychowsky JE, Kawai K, Moritz E, Rahbar R, Adil EA. To stent or not to stent? A meta-analysis of endonasal congenital bilateral choanal atresia repair. Laryngoscope. 2016 Jan;126(1):218-27. doi: 10.1002/lary.25393. Epub 2015 May 25.
citation: Murr AH, Smith TL, Hwang PH, Bhattacharyya N, Lanier BJ, Stambaugh JW, Mugglin AS. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011 Jan-Feb;1(1):23-32. doi: 10.1002/alr.20020. Epub 2011 Feb 8.
citation: Bangiyev JN, Govil N, Sheyn A, Haupert M, Thottam PJ. Novel Application of Steroid Eluting Stents in Choanal Atresia Repair: A Case Series. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):79-82. doi: 10.1177/0003489416671533. Epub 2016 Oct 7.
citation: Wilcox LJ, Smith MM, de Alarcon A, Epperson M, Born H, Hart CK. Use of Steroid-Eluting Stents after Endoscopic Repair of Choanal Atresia: A Case Series with Review. Ann Otol Rhinol Laryngol. 2020 Oct;129(10):1003-1010. doi: 10.1177/0003489420928374. Epub 2020 May 29.
citation: Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A, Rosen JP, Ruff ME, Vandewalker ML, Wanderer A, Damaraju CV, Nolop KB, Mesarina-Wicki B. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics. 2000 Feb;105(2):E22. doi: 10.1542/peds.105.2.e22.