Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID05180253

Healthy Control Esophageal and Gastric Registry and Biorepository

Led by University of Louisville · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the foregut, including the esophagus and stomach, to improve clinical evaluation methods for foregut physiology. This observational study focuses on healthy, asymptomatic volunteers to gather data on esophageal peristalsis and reflux disease using new diagnostic tools. These tools, EndoFLIP and mucosal integrity (MI) assessments, are performed during upper endoscopy and aim to provide quick, less uncomfortable alternatives to traditional methods. The study is sponsored by the University of Louisville and targets establishing normal reference values for these assessments. Participants will undergo esophageal and pyloric testing using EndoFLIP and MI during standard upper endoscopy procedures. These tests involve a balloon placed through the endoscope to assess esophageal and pyloric function and mucosal integrity without additional significant risk or discomfort. The study will collect diagnostic data and blood samples from healthy subjects to help define normal esophageal and gastric parameters. During the study, participants will complete gastroesophageal and gastric symptom questionnaires to confirm their asymptomatic status. Researchers will measure normative mucosal integrity and pyloric FLIP values over one year. The study excludes participants with prior gastrointestinal surgery, certain medical conditions, or medication use that could affect results. Participation involves one-time testing during endoscopy, with data collection focused on establishing benchmarks for future patient assessments.

CONDITIONS

Brief 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 between 18 and 85 years
  • No prior surgical history
  • Asymptomatic on gastroesophageal and gastric symptom questionnaires
  • Not currently taking medications affecting acid secretion or gut motility
  • No history of malignancy
  • No mental health issues affecting informed consent
  • No history of smoking
  • No excessive or daily alcohol use
  • BMI under 30
  • No known hiatus hernia
  • No known medical illnesses like autoimmune or neurological conditions 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...

  • Under 18 years of age
  • Previous surgeries involving the gastrointestinal tract
  • Use of medications affecting acid secretion or gut motility
  • Personal history of malignancy
  • Mental health issues preventing informed consent
  • Presence of symptoms on standard clinical questionnaires
  • Pregnant women
  • Nursing women due to medication effects and procedure time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo esophageal and blood testing to collect diagnostic data.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants are observed to establish normative values over one year.

Follow-up assessments may occur depending on study procedures

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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Frequently Asked Questions

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