Esophageal Monitoring Device for Assessing Mucosal Impedance

GERD Clinical Trial

Official title:

Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556919
• Other study ID #: 120126
• Status: Completed
• Start date: March 2012
• Est. completion date: July 23, 2021

Study information

• Verified date: July 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: July 23, 2021
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• GERD

Intervention

Procedure:
• Standard of care endoscopy
standard of care endoscopy

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Endoscopy Laboratory	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal Impedance Values	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.	Values will be obtained at conclusion of EGD, an expected average of 5 minutes