Use of Mometasone Eluting Stent in Choanal Atresia

Cincinnati Children's Hospital Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Choanal Atresia

Treatments: Drug: Drug-eluting Stent Mometasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03605537

2018-1813

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Stent

Experimental group

Description:

Subjects will undergo repair of the choanal atresia in the operating room with a drug eluting stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. At this time in the operating room the intervention arm will have the stent removed. Following removal of the stent, photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care). Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps).

Treatment:

Drug: Drug-eluting Stent Mometasone

No Stent

No Intervention group

Description:

Subjects will undergo repair of the choanal atresia in the operating room with no stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. Photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care). Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps).