Esophageal Monitoring Device for Assessing Mucosal Impedance

Completed

• Conditions: Esophagitis; GERD
• Interventions: Procedure: Standard of care endoscopy

• Registration Number: NCT01556919
• Lead Sponsor: Vanderbilt University

Brief Summary

The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.

Detailed Description

During routine esophagogastroduodenoscopy (EGD), consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. Each catheter will be manually guided by the physician through the working channel of the endoscope until the sensored tip is visible through the scope camera. The physician will place the sensored rings directly on the mucosa along the lumen. To obtain evaluable data, the sensors must remain in contact with the mucosa at each point for 5 seconds after a stable impedance reading has been captured. This process will be repeated for each of the three prototype catheters in each consented patient in order to determine the optimal catheter/sensor design. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Status Verified: 2021-07
• Primary Completion: 2021-07-23
• Study Completion: 2021-07-23
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

• Patients who are undergoing standard of care EGD with or without BRAVO placement;
• Have GERD symptoms and/or have endoscopic esophagitis

Exclusion Criteria

• Use of acid suppressive therapy within last 10 days;
• Known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mucosal Impedance Probe	Standard of care endoscopy	-

Primary Outcome Measures

Name	Time	Method
Mucosal Impedance Values	Values will be obtained at conclusion of EGD, an expected average of 5 minutes	Consented study participants will have a series of three (3) custom mucosal impedance (MI) catheters with an axial array of sensors positioned along the mucosal wall to directly measure mucosal impedance at various intervals. The catheters will be attached to a channeled feed that will record measurements on a dedicated computer.

Trial Locations

Locations (1)

Vanderbilt University Medical Center Endoscopy Laboratory; 🇺🇸 Nashville, Tennessee, United States