Diagnostic tests for supra-esophageal gastroesophageal reflux disease
Development of Physiology- and Pathophysiology-based Diagnostic Tests and Therapeutics for Patients With Pharyngeal Reflux of Gastric Content
This study is testing new ways to understand and measure throat reflux in people with gastroesophageal reflux disease (GERD) to see if a specific pressure technique can help prevent it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05695846 on ClinicalTrials.gov |
What this trial studies
This study aims to define the manometric characteristics of upper esophageal sphincter (UES) incompetence associated with pharyngeal reflux in patients suffering from gastroesophageal reflux disease (GERD). It will assess the reproducibility of these manometric criteria and evaluate the effectiveness of externally applied cricoid cartilage pressure in preventing pharyngeal reflux. The study will involve concurrent video-pharyngo-laryngoscopy, high-resolution manometry, impedance recording, and pH monitoring to gather comprehensive data on reflux events and related functions. Patients will be monitored in a supine position to ensure safety during the procedures.
Who should consider this trial
Good fit: Ideal candidates include GERD patients experiencing regurgitation along with supra-esophageal symptoms such as chronic cough or hoarse voice.
Not a fit: Patients with functional heartburn or those outside the age range of 20 to 85 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients suffering from supra-esophageal symptoms related to GERD.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section). * History of allergy to Lidocaine for nasal topical anesthesia.
Where this trial is running
Milwaukee, Wisconsin
- Reza Shaker — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Reza Shaker, MD — Medical College of Wisconsin
- Study coordinator: Reza Shaker, MD
- Email: rshaker@mcw.edu
- Phone: 4149556840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.