Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 90 Years|
- - Adults ages 18-90 undergoing clinically indicated upper endoscopy - Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy - Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.
Exclusion criteria:- Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy - Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome - Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|David Katzka, MD|
|Principal Investigator Affiliation||Mayo Clinic|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Mucosal Impedance
Patients with Eosinophilic Esophagitis and patient without trouble swallowing,during your clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it. The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds. At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds.
Device: - Mucosal Impedance
Mucosal impedance- a (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds. At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds. This will determine if people with eosinophilic esophagitis (EoE) have an increased esophageal mucosa impedance (food getting into the esophageal tissue).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.