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Use of Mometasone Eluting Stent in Choanal Atresia

NCT03605537 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-04-06

No results posted yet for this study

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.

Conditions

  • Choanal Atresia

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Catherine Hart, MD · CCHMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2019-10-11
Completion
2019-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03605537 on ClinicalTrials.gov