Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT05180253

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

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Norton Healthcare

Louisville, Kentucky, United States, 40202

Actively Recruiting

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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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Esophageal and Gastric Registry and Biorepository | DecenTrialz