WITHDRAWN

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of Physiology- and Pathophysiology-based Diagnostic Tests and Therapeutics for Patients With Pharyngeal Reflux of Gastric Content

Quick Facts

Study Start:2014-01-29
Study Completion:2025-04-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05695846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  1. * Age \<20 or \>85
  2. * History or active alcohol or drug abuse
  3. * History of upper GI and ears, nose, throat and pulmonary diseases that may affect the oropharyngoesophageal axis and stomach
  4. * History of malignancy and chemo-radiation therapy
  5. * Unable to give consent
  6. * Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section).
  7. * History of allergy to Lidocaine for nasal topical anesthesia.

Contacts and Locations

Principal Investigator

Reza Shaker, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

Reza Shaker
Milwaukee, Wisconsin, 53086
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Reza Shaker, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-01-29
Study Completion Date2025-04-02

Study Record Updates

Study Start Date2014-01-29
Study Completion Date2025-04-02

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroesophageal Reflux