Use of Mometasone Eluting Stent in Choanal Atresia

Choanal Atresia Clinical Trial

Official title:

Use of Mometasone Eluting Stent in Choanal Atresia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03605537
• Other study ID #: 2018-1813
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 3, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: April 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choanal Atresia

Intervention

Drug:
• Drug-eluting Stent Mometasone
The subject will have a mometasone drug-eluting stent placed during their choanal atresia repair procedure instead of no stent being placed.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Epub 2016 Oct 7. — View Citation

Deutsch E, Kaufman M, Eilon A. Transnasal endoscopic management of choanal atresia. Int J Pediatr Otorhinolaryngol. 1997 May 4;40(1):19-26. Review. — View 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. Erratum in: Int Forum Allergy Rhinol. 2019 Aug;9(8):945. — View 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. — View 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. — View Citation

Wilcox LJ, Smith MM, de Alarcon A, Born H, Epperson M, Hart CK. Use of steroid eluting stent after endoscopic repair of choanal atresia: a case series with review. Submitted for presentation at AAO-HNS Annual Scientific Meeting, Atlanta, GA Oct 7-10, 2018.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Posterior Nasal Cavity	Once photodocumentation from followup visits is collected, the images will be collected by a member of the team and given to two independent expert blinded reviewers for assessment of the size of the posterior nasal cavity. The picture will be obtained from the same anatomical position for each scope (the posterior portion of the inferior turbinate) and compared to the picture immediately after surgery of the posterior nasal cavity to assess any changes in size. Reviewers will assess the size of the posterior nasal cavity in each subsequent scope and categorize subjects based on the following sizes (0-50%, 51-75%, 76-100%).	12 Months