Actively Recruiting
Esophageal and Gastric Registry and Biorepository
Led by University of Louisville · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Esophageal and Gastric Registry and Biorepository
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-85 years
- No prior surgical history
- Asymptomatic based on gastroesophageal and gastric questionnaires
- Not taking medications affecting acid secretion or gut motility
- No history of malignancy
- No mental health issues preventing informed consent
- No history of smoking
- No excessive or daily alcohol use
- Body mass index (BMI) under 30
- No known hiatus hernia
- No medical illness like autoimmune or neurological disorders affecting esophageal or gastric function
- Not allergic to fentanyl or versed
- No history of eating disorders
- No history of autoimmune disorders
You will not qualify if you...
- Younger than 18 years or older than 85 years
- Surgeries involving the gastrointestinal tract
- Use of medications affecting acid secretion or gut motility
- Personal history of cancer
- Mental health issues preventing informed consent
- Symptoms on standard clinical questionnaires
- Pregnant women
- Nursing women due to medication effects and procedure length
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Norton Healthcare
Louisville, Kentucky, United States, 40202
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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