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External UES Band for GERD with Ear, Nose, and Throat Symptoms

This study is looking into how well an external upper esophageal band, called the Shaker Pressure Band, can help reduce nighttime symptoms of gastroesophageal reflux disease (GERD). GERD is a common condition where stomach acid flows back into the esophagus (the tube connecting your mouth to your stomach). This study is for people aged 18 to 85 who have GERD and also experience symptoms in their ears, nose, or throat, chronic cough, choking, or food coming back up. We'll be looking at how your symptoms change after one week of using the band. The study plans to enroll 350 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 350 participants. The study aims to assess the effectiveness of the Shaker Pressure Band.
What's involved
Participants will have an initial physician assessment and then another assessment after one week of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at the initial physician assessment and after one week of treatment.

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NCT05697393

External UES Band (Shaker Pressure Band) and GERD

Recruiting
NAAges 18–85InterventionalTreatment
Medical College of Wisconsin
~350 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Shaker Pressure Band

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptom Analysis
Measured over Initial physician assessment and after one week of treatment

Conditions

Gastroesophageal Reflux

Explore related trials

Gastroesophageal Reflux

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Reza Shaker · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Reza Shaker, MD
[email protected]
4149556840
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The patient must be 18 years of age or older.
Patients with gastroesophageal reflux disease (GERD) who has ear, nose, and throat symptoms, chronic cough, choking, or regurgitation (food coming back up into the throat).
The patient has been diagnosed with GERD with extra-esophageal symptoms, esophagitis, hiatal hernia, achalasia, or diffuse esophageal spasm.
The patient must not be pregnant or lactating.

Exclusion

The patient cannot be younger than 18 years of age or older than 85.
The patient cannot have sleep apnea or be on CPAP
Patient cannot have previous head or neck surgery or radiation.
Patient cannot have carotid artery disease, thyroid disease or history of cerebral vascular disease.
Patients with an inability to tolerate nasal intubation.
Patients with significant bleeding disorders for whom nasal intubation has been deemed contraindicated
Patients with a known esophageal obstruction prevent passage of the manometry probe.

What this trial measures

  • Symptom AnalysisInitial physician assessment and after one week of treatment

    Patients will be evaluated and categorized by their symptoms at the time of their clinical physician's assessment. All patients will then undergo the same study procedures already approved for this protocol and evaluate the change in their symptoms using the evaluation forms currently available in this protocol.