Trials / Completed
CompletedNCT01556919
Esophageal Monitoring Device for Assessing Mucosal Impedance
Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 429 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard of care endoscopy | standard of care endoscopy |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2021-07-23
- Completion
- 2021-07-23
- First posted
- 2012-03-19
- Last updated
- 2021-08-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01556919. Inclusion in this directory is not an endorsement.