About this trial
The evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. Assessing esophageal peristalsis has relied for the past several decades on High Resolution Manometry (HRM), however it has recently become known that even though HRM is an extremely effective tool, that there are certain subsets of patients in which additional information is required. Additionally, the assessment of esophageal reflux disease has relied on pH impedance for the last two decades. However, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. Novel techniques, already FDA approved, including EndoFLIP for esophageal peristalsis and mucosal integrity (MI) for reflux disease, have emerged as time-of-endoscopy assessments. Both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. However, data regarding normal esophageal parameters are poorly defined for both EndoFLIP and MI. Additionally, EndoFLIP has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the GI tract.
We will recruit healthy, asymptomatic volunteers to undergo testing with MI and FLIP (esophageal and pyloric). The data obtained will help establish the benchmark from which assessments can be made in patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-85
No prior surgical history
Asymptomatic according to gastroesophageal and gastric questionnaires
Not currently taking any medications that affect acid secretion or gut motility
Disqualifiers
Minors
Surgeries involving the GI tract
Medication use affecting acid secretion or gut motility
Personal history of malignancy
Trial population
Adults 18-85 years of age, free of esophageal symptoms, never diagnosed with esophageal disorders, never diagnosed with an autoimmune disease, able to provide informed consent, and willing and able to undergo esophageal physiologic studies and biopsies.
Trial design
Cohort
Prospective
Treatments tested in this trial
Esophageal studies
Diagnostic testHealthy subjects will undergo esophageal and blood testing.
Treatment groups
Trial outcomes
Primary outcomes
Normative mucosal integrity values
We will establish the range of MI values in healthy, asymptomatic individuals.
Normative pyloric FLIP values
We will further establish the range of FLIP values that can be seen in healthy, asymptomatic individuals.
Sponsors and contacts
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