Tympanostomy Tubes Versus Eustachian Tube Dilation

NCT03886740 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

Summary

The objective of this study is to determine whether tympanostomy with pressure equalization tube placement or Eustachian tube (ET) dilation is superior at reducing symptoms of patients with ET dysfunction.

Given the apparent promise of Eustachian tube dilation and the lack of head to head comparison to the more traditional tympanostomy tube, this study seeks to compare them in a head to head manner in order to assess superiority in regards to ETDQ-7 and tympanogram improvements.

Conditions

  • Eustachian Tube Dysfunction
  • Eustachian Tube Dysfunction of Left Ear
  • Eustachian Tube Dysfunction of Right Ear (Diagnosis)
  • Eustachian Tube Dysfunction of Both Ears (Diagnosis)

Interventions

PROCEDURE

Reducing symptoms of Eustachian tube dysfunction

One of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared

Sponsors & Collaborators

Principal Investigators

  • Ana Kim, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2021-08-31
Completion
2021-08-31

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Entities

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 NCT03886740 on ClinicalTrials.gov