Balloon Dilation for Eustachian Tube Dysfunction

This trial explores whether balloon dilation of the eustachian tube, using the Stryker XprESS LoProfile ENT dilation system, can effectively treat eustachian tube dysfunction, which causes ear pain, pressure, and muffled hearing. Participants will receive either the balloon dilation treatment or a simulated procedure. Researchers aim to determine if the actual procedure is more effective than the simulation. They also seek to identify which types of patients benefit most from the treatment and confirm its safety. Individuals with persistent ear issues for over three months, despite using nasal sprays or steroids, might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially find relief from persistent ear issues.

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that symptoms should persist despite using nasal steroid sprays or systemic steroids, suggesting you might continue these treatments if they are not effective.

Research has shown that using a balloon to widen the eustachian tube is generally safe for treating related problems. Studies have found that many patients experience relief after the procedure. For example, the Valsalva maneuver, a test for ear pressure, showed improvement in 80-98% of patients.

Side effects are rare. In one report, a patient underwent the procedure without any issues. Another study found that balloon dilation is a safe choice with few problems reported, indicating that the treatment is usually well-tolerated.

Balloon dilation for Eustachian tube dysfunction is unique because it offers a minimally invasive way to directly address blockages in the Eustachian tube. Traditional treatments usually involve medications like decongestants or surgery, which can be more invasive and come with longer recovery times. This procedure uses the Stryker XprESS LoProfile ENT dilation system to gently expand the Eustachian tube, potentially improving function with less discomfort and quicker recovery. Researchers are excited about this method because it could provide faster relief with fewer side effects, making it a promising alternative for those struggling with chronic ear issues.

Research has shown that using a balloon to widen the eustachian tube can effectively treat related problems. One study found that 80–98% of patients experienced easier pressure balance in their ears, which is crucial for comfort. Additionally, 73–98% of patients reported symptom improvement. Tests measuring eardrum movement showed better results in over 50% of patients from the start to six weeks post-treatment. In this trial, participants will either undergo balloon dilation of the eustachian tube or a sham procedure. These findings suggest balloon dilation is a promising option for those with eustachian tube issues.²⁴⁶⁷⁸