RECRUITING

External UES Band (Shaker Pressure Band) and GERD

Conditions

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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

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.

Official Title

External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease

Quick Facts

Study Start:2011-01-25

Study Completion:2024-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05697393

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:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Reza Shaker, MD

CONTACT

4149556840

rshaker@mcw.edu

Mark Kern

CONTACT

4148053826

mkern@mcw.edu

Principal Investigator

Reza Shaker

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Reza Shaker, 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 Date2011-01-25

Study Completion Date2024-11-30

Study Record Updates

Study Start Date2011-01-25

Study Completion Date2024-11-30

Terms related to this study

Additional Relevant MeSH Terms

Gastroesophageal Reflux