Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05180253
Study type Interventional
Source University of Louisville
Status Not yet recruiting
Phase N/A
Start date January 2022
Completion date November 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04202692 - Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment N/A
Recruiting NCT03646045 - Transpyloric Feeding for Prevention of Micro-aspiration
Completed NCT04268719 - Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease
Recruiting NCT04614974 - Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia Phase 1/Phase 2
Recruiting NCT03868267 - Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting
Recruiting NCT04028466 - Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features Phase 4
Recruiting NCT05066594 - Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Completed NCT03476265 - Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility N/A
Completed NCT03143608 - GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery N/A
Completed NCT04436159 - Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. N/A
Completed NCT03258528 - Effect of Right Lateral Position on Ventilated Preterm Neonates N/A
Recruiting NCT04500288 - The Effect of Positional Therapy on Symptoms of Gastroesophageal Reflux Disease: A Prospective Pilot Study N/A
Recruiting NCT04846010 - Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2 Phase 1/Phase 2
Recruiting NCT03835663 - The Bacterial Composition of the Stomach in Reflux Disease
Completed NCT03881722 - Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux. Phase 3
Completed NCT04410211 - Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures N/A
Not yet recruiting NCT04400136 - PPI Therapy Impact on GERD After Sleeve Gastrectomy Early Phase 1
Recruiting NCT04085211 - Image-Enhanced Endoscopy in the Gastrointestinal Tract
Enrolling by invitation NCT03202537 - Effectiveness of Physiologic Testing in PPI Non-Responders Early Phase 1
Not yet recruiting NCT04105894 - Gastric Reflux and Sinonasal Symptoms