Diagnostic Tests in Supra-Esophageal Gastroesophageal Reflux Disease (SE-GERD)

NCT05695846 | Withdrawn FDA Device

• 1 other identifier: PRO00020732
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Endoscopic evidence of supra-esophageal reflux

  Visually confirmed supra-esophageal refluxate seen during video endoscopy and log the number of reflux episodes duing each simulated esophageal reflux infusion

  Procedure (During simulated reflux perfusion of the esophagus)

Study Arms (1)

Patients with supra-esophageal gastroesophageal reflux disease

OTHER

GERD patients with complaints of regurgitation and supra-esophageal symptoms

Device: externally applied cricoid cartilage pressure

Interventions

externally applied cricoid cartilage pressure DEVICE

Patients with supra-esophageal gastroesophageal reflux disease

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).

You may not qualify if:

• Age \<20 or \>85
• History or active alcohol or drug abuse
• History of upper GI and ears, nose, throat and pulmonary diseases that may affect the oropharyngoesophageal axis and stomach
• History of malignancy and chemo-radiation therapy
• Unable to give consent
• History of allergy to Lidocaine for nasal topical anesthesia.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Reza Shaker

Milwaukee, Wisconsin, 53086, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Reza Shaker, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analysis staff will be blinded with regard to patient status.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• 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

Model Details: GERD patients with complaints of regurgitation and supra-esophageal symptoms

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 29, 2014
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)