External UES Band (Shaker Pressure Band) and GERD

NCT05697393 | Recruiting

• 1 other identifier: PRO00014424
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Symptom Analysis

  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.

  Initial physician assessment and after one week of treatment

Study Arms (2)

Shaker Pressure Band GERD patients with external laryngeal pressure

ACTIVE COMPARATOR

One week of Shaker pressure band

Device: Shaker Pressure Band

Shaker Pressure Band GERD patients without external laryngeal pressure

PLACEBO COMPARATOR

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

Device: Shaker Pressure Band

Interventions

Shaker Pressure Band DEVICE

Shaker Pressure Band GERD patients with external laryngeal pressure; Shaker Pressure Band GERD patients without external laryngeal pressure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Reza Shaker

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Shaker, MD

CONTACT

4149556840; rshaker@mcw.edu

Mark Kern

CONTACT

4148053826; mkern@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 25, 2011
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)