Eustachian Tube Dysfunction Clinical Trial
Official title:
Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
Verified date | October 2017 |
Source | Hillel Yaffe Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram. 2. OME and/or TM atelectasis 3. Type B or C tympanograms 4. Inability to inflate middle ears by Valsalva maneuver. 5. Patients performed tympanocentesis and patients underwent tube insertion will be included. Exclusion Criteria: 1. Children less than 18 years old. 2. Patients with an active infection. 3. Patients with craniofacial abnormalities. 4. Pregnancy? |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hillel Yaffe Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in eustachian tube function | Otoscopy | 1,3,6 and 12 month post procedure |
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