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NCT05180253 · ClinicalTrials.gov registry record

Esophageal and Gastric Registry and Biorepository

A clinical trial of Gastro Esophageal Reflux, sponsored by University of Louisville.

Recruiting
Registry status
40
Enrollment target
1
Study location

NCT05180253 is a study of Gastro Esophageal Reflux that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 40 participants, below the 12,940-participant average among 7 other Gastro Esophageal Reflux trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05180253, a study of Gastro Esophageal 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.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Esophageal studies

Study Locations (1)

Kentucky

  • Norton Healthcare - Louisville

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-01-09
Est. Completion 2025-11

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT05180253

The ClinicalTrials.gov registry entry for NCT05180253 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,940-participant average among 7 other Gastro Esophageal Reflux trials with a reported enrollment target (100% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastro Esophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which Esophageal studies is the first listed.

NCT05180253 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Gastro Esophageal 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.

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