Clinical Trials Logo
  1. Home
  2. Eustachian Tube Dysfunction
  3. NCT05270031

Balloon Dilation of the Eustachian Tube — BDET  

Eustachian Tube Dysfunction Clinical Trial

Official title:
A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon

Clinical Trial Summary

In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Clinical Trial Description

Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day Regular Follow up with Tympanogram and Questionnaire After three months patient in the control group (nasal saline) can switch in the intervention group. Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05270031
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact
Status Terminated
Phase N/A
Start date February 24, 2022
Completion date August 28, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04776967 - Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study. N/A
Recruiting NCT04804098 - Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study. N/A
Terminated NCT01974726 - Gas Supply, Demand and Middle Ear Gas Balance -- Diagnosis of Eustachian Tube Dysfunction N/A
Recruiting NCT05600595 - The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children
Not yet recruiting NCT05998356 - Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease N/A
Not yet recruiting NCT03322579 - Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge N/A
Withdrawn NCT03886740 - Tympanostomy Tubes Versus Eustachian Tube Dilation N/A
Completed NCT04809753 - Eustachian Tube Dilation With an Endovascular Balloon N/A
Withdrawn NCT02631187 - Feasibility Study of Balloon Eustachian Tuboplasty (BET) N/A
Completed NCT04902963 - What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube? N/A
Completed NCT04136977 - XprESS ET Registry
Completed NCT03197558 - Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT) Phase 2
Recruiting NCT05719207 - Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction N/A
Completed NCT01251432 - Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults N/A
Recruiting NCT05055115 - Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis N/A
Recruiting NCT04645511 - Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis. N/A
Not yet recruiting NCT05222230 - FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing N/A
Completed NCT02667301 - Eustachian Tube Dysfunction Assessment N/A
Not yet recruiting NCT05229380 - Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube
Completed NCT03850197 - Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing