Recruiting

External UES Band

Sponsor:

Medical College of Wisconsin

Code:

NCT05697393

Conditions

Gastroesophageal Reflux

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Shaker Pressure Band

Study Details

Brief summary:

This protocol is a study to assess the efficacy of an external upper esophageal band to decrease subjective nighttime symptoms related to esophageal reflux into the pharynx.

Conditions

Gastroesophageal Reflux

Study ID

NCT05697393

Start date

Jan 25, 2011

Status verified date

Mar, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Shaker Pressure Band GERD patients with external laryngeal pressure

One week of Shaker pressure band

placebo comparator: Shaker Pressure Band GERD patients without external laryngeal pressure

One week of sham Shaker pressure band (no external laryngeal pressure)

Interventions

Shaker Pressure Band

Primary outcome measure

  • Symptom Analysis [ Time Frame: Initial physician assessment and after one week of treatment ]

Central Contacts and Locations

Central contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

Contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-09.