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NCT05180253 · ClinicalTrials.gov registry record
Esophageal and Gastric Registry and Biorepository
A clinical trial of Gastroesophageal Reflux, sponsored by University of Louisville.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT05180253: Recruiting study of Gastroesophageal Reflux, sponsored by University of Louisville.
NCT05180253 is a study of Gastroesophageal Reflux that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 40 participants, below the 2,885-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05180253, a study of Gastroesophageal Reflux, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
We will establish the range of MI values in healthy, asymptomatic individuals.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Esophageal studies
Study Locations (1)
Kentucky
- Norton Healthcare - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2025-11 |
What NCT05180253 shows while recruiting
NCT05180253 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,885-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which Esophageal studies is the first listed.
NCT05180253 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT05180253 about?
NCT05180253 is a clinical study titled "Esophageal and Gastric Registry and Biorepository". 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 Mano...
What is the current status of trial NCT05180253?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2023-01-09. Estimated completion is 2025-11.
What conditions does trial NCT05180253 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux.
What interventions are being tested in trial NCT05180253?
The interventions under investigation include: Esophageal studies (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05180253?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05180253 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux
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Where NCT05180253's enrollment target sits among peer trials
40 27th of 33 higher than 6 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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