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Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia

NCT04055714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-14

No results posted yet for this study

Summary

The objective of this study is to demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels.

Conditions

  • Chronic Eustachian Salpingitis

Interventions

DEVICE

Balloon dilation of the Eustachian tubes

Use the Aera Balloon through the nose to dilate the Eustachian tubes

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Piedmont Ear, Nose, Throat and Related Allergy, PC

    lead OTHER

Principal Investigators

  • Karen Hoffmann, MD · Piedmont Ear, Nose, Throat & Related Allergy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-10-31
Completion
2021-10-31
FDA Device
Yes

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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 NCT04055714 on ClinicalTrials.gov