Trials / Withdrawn
WithdrawnNCT03605537
Use of Mometasone Eluting Stent in Choanal Atresia
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-07-03
- Primary completion
- 2019-10-11
- Completion
- 2019-10-11
- First posted
- 2018-07-30
- Last updated
- 2021-04-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03605537. Inclusion in this directory is not an endorsement.