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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01556919
Other study ID # 120126
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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