Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge

NCT03322579 | Unknown FDA Device

• 1 other identifier: 0034-17
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change in eustachian tube function

  Otoscopy

  1,3,6 and 12 month post procedure

Study Arms (1)

Patients with Eustachian tube dysfunction

EXPERIMENTAL

Device: Balloon dilatation Eustachian tuboplasty

Interventions

Balloon dilatation Eustachian tuboplasty DEVICE

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.

Patients with Eustachian tube dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
• OME and/or TM atelectasis
• Type B or C tympanograms
• Inability to inflate middle ears by Valsalva maneuver.
• Patients performed tympanocentesis and patients underwent tube insertion will be included.

You may not qualify if:

• Children less than 18 years old.
• Patients with an active infection.
• Patients with craniofacial abnormalities.
• Pregnancy?

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Related Publications (1)

• Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

  PMID: 40008607 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Unilateral or bilateral balloon catheter dilation will be performed on patients with eustachian tube dysfunction

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: October 26, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10