Esophageal Monitoring Device for Assessing Mucosal Impedance
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/21/2018 |
| Start Date: | March 2012 |
| End Date: | December 2019 |
| Contact: | Tina Higginbotham, MPA |
| Email: | tina.higginbotham@vanderbilt.edu |
| Phone: | 615-322-4643 |
Development of an Esophageal Monitoring Device for the Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
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.
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.
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.
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
We found this trial at
1
site
Nashville, Tennessee 37232
Principal Investigator: Michael F Vaezi, MD, PhD
Phone: 615-322-4643
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