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Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

NCT01507207 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-20

No results posted yet for this study

Summary

Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging science. The largest published series of pediatric patients with type I laryngeal clefts shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of treatment. A comparison of quality of life outcomes before and after injection laryngoplasty has not been carried out. The investigators hypothesize that injection laryngoplasty significantly improves symptoms and quality of life related to dysphagia in a pediatric population with laryngeal clefts.

Conditions

Interventions

PROCEDURE

Injection laryngoplasty

Patients will undergo a direct microlaryngoscopy in the operating room for diagnostic purposes. In patients in whom laryngeal cleft is diagnosed, injection laryngoplasty will be carried out using sodium carboxymethylcellulose aqueous gel (commercial name Radiesse) injection material.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Carol MacArthur, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-05-15
Completion
2015-05-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01507207 on ClinicalTrials.gov