Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the long-term effects of a procedure called Balloon Eustachian Tuboplasty (BET) on people with a condition known as Obstructive Eustachian Tube Dysfunction (OETD). This condition can cause issues like ear pain, fullness, or hearing problems. While many BET procedures have been done worldwide, doctors want to better understand how effective it really is. This study will be one of the first to use a method called a "blinded randomized controlled trial," which means that neither the participants nor the researchers will know who is receiving the treatment or a placebo. This helps ensure the results are reliable.

To be eligible for this trial, participants should be between 18 and 85 years old and have specific symptoms related to OETD that haven't improved with standard medical treatments. They should also have a certain score indicating the severity of their condition. Participants will need to attend regular visits to monitor their progress and complete various trial procedures. It's important to note that individuals with certain medical histories or conditions, such as previous ear surgeries or severe medical issues, will not be able to participate. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 85 years
• • Clinical symptoms of OETD with Eustachian tubal score less or equal to 7/14
• • Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more
• • ASA score 1 or 2 (ASA : American Society of Anesthesiologists)
• Exclusion Criteria:
• • Palatal cleft
• • Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side
• • Medical history of nasopharyngeal radiotherapy
• • Medical history of middle ear surgery (except myringotomy and/or tympanostomy tube)
• • Eardrum perforation in the treated side
• • Contraindication of general anesthesia, or major risk of general anesthesia including ASA scores of 3 and 4
• • Major nasal obstruction ipsilateral to the Eustachian tube to treat
• • Medical history of previous Eustachian Tube Dilation
• • Pregnant or nursing woman, or in childbearing age and not willing to use contraception
• • Inclusion in another interventional clinical trial
• • Protected and vulnerable adult
• • Not covered by Health insurance
• • Refusal to sign informed consent form
• • Subjects unable to attend all scheduled visits or to comply with all trial procedures