Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04960566
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects (females of childbearing potential should be on highly effective contraceptive methods)
* Aged 18-80 years old
* Mentally capable to provide informed consent
* Fluent in English
* Have symptoms of GERD (heartburn, regurgitation, and non-cardiac chest pain)
* Have failed an appropriate compliant trial of PPI therapy with a GERDQ score ≥6.
* Able to undergo endoscopy, ambulatory reflux monitoring, and manometry
* Be interested in behavioral interventions for ongoing symptoms.
Exclusion Criteria:
* Participation in a concurrent clinical trial or completed another trial within past 8 weeks.
* Active severe erosive esophagitis (Los Angeles Grade C or D), Long segment Barrett's esophagus (Zap score of 4)
* Prior gastrointestinal surgery of the esophagus and/or stomach
* Current signs or symptoms of heart disease. All patients with non-cardiac chest pain are required to have a cardiologist evaluation as standard of care work up in the evaluation of non-cardiac chest pain.
* Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the investigator can be included.
* History of drug addiction, drug abuse or alcoholism.
* Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
* Pregnant patients.
* Special vulnerable populations including children, prisoners, institutionalized individuals.
* Bleeding disorder or requirement of NSAID/aspirin during monitoring period.
* Drugs that affect gastrointestinal symptoms (H2 blockers, antacids, metoclopramide, domperidone, erythromycin, anticholinergics \[bentyl, levsin, belladonna etc.\]). Antidepressants can be continued at stable dose.
* Patients found to have achalasia, a spastic disorder, hypercontractile disorder or functional obstruction at the esophagogastric junction will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04960566
Study Brief:
Protocol Section:
NCT04960566