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Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge

NCT03322579 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-26

No results posted yet for this study

Summary

Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.

Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction. Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.

The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.

Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.

Conditions

  • Eustachian Tube Dysfunction

Interventions

DEVICE

Balloon dilatation Eustachian tuboplasty

Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-11-30
Completion
2018-12-31
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 NCT03322579 on ClinicalTrials.gov