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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucosal Impedance Probe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care endoscopy | Procedure | standard of care endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for an esophagogastroduodenoscoy (EGD) for one of the following reasons: diagnosed with Gastroesophegeal reflux disease (GERD); have a normal esophageal mucosa but an abnormal pH testing (acid measurement); or a normal esophagus and normal pH testing
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center Endoscopy Laboratory | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25448923 | Derived | Ates F, Yuksel ES, Higginbotham T, Slaughter JC, Mabary J, Kavitt RT, Garrett CG, Francis D, Vaezi MF. Mucosal impedance discriminates GERD from non-GERD conditions. Gastroenterology. 2015 Feb;148(2):334-43. doi: 10.1053/j.gastro.2014.10.010. Epub 2014 Oct 16. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |