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||22 Years and Over|
- - Greater than or equal to 22 years of age.
- - Known EoE.
- - Previously scheduled upper endoscopy at the University of Pennsylvania.
- - do not meet inclusion criteria.
- - do not want to participate.
- - known or suspected contraindication for esophageal intubation.
- - esophageal stricture with inability to pass an endoscope.
- - history of esophageal perforation.
- - history of esophageal resection.
- - esophageal diverticula.
- - esophageal fistula.
- - pill dysphagia.
- - pill swallowing phobia.
- - food impaction.
- - esophageal varices.
- - coagulopathy.
- - active anticoagulation or antithrombotic.
- - active GI bleeding.
- - pregnancy.
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.
|University of Pennsylvania|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Gary W Falk, MD|
|Principal Investigator Affiliation||University of Pennsylvania|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Eosinophilic Esophagitis, Diagnoses Disease|
Background Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus characterized by esophageal eosinophilia that can lead to esophageal remodeling and stricture formation. To assess remission, upper endoscopy (EGD) with biopsies is performed. This is an invasive procedure and contributes to cost burden for patients. It is important to assess non-invasive techniques to sample the cells of the esophagus. There have been a few non-invasive testing modalities suggested, including the esophageal string test and Cytosponge. These involve swallowing a string or capsule that ultimately collects esophageal cells. The string test study showed a significant correlation with traditional biopsy pathology, however, limitations included the string remaining in overnight and potential contamination from oral flora. Katzka et al showed that the Cytosponge had an 86% specificity with limitations including gelatin allergy, local esophageal abrasions and similar potential oral contamination as the esophageal string test. Another promising device is EsoCheck. This is an encapsulated balloon that can be easily swallowed and collect cells from the distal esophagus. It is well tolerated and, in Barrett's esophagus, detected metaplasia with 91.7% specificity. The primary aims of this study are to determine the feasibility and safety of EsoCheck compared with standard endoscopy and biopsies in the assessment of EoE. Secondary aims include specific and sensitivity of EsoCheck as well as specificity and sensitivity of brush cytology given that EsoCheck is a cytology device. Detailed Description Study design This is a prospective pilot study at the University of Pennsylvania to evaluate feasibility and safety. Inclusion criteria include patients at least 22 years of age with known EoE diagnosed in accordance with consensus guidelines previously scheduled upper endoscopy at the University of Pennsylvania. Exclusion criteria include: known or suspected contraindication for esophageal intubation, esophageal stricture with inability to pass an endoscope, history of esophageal perforation, history of esophageal resection, esophageal diverticula, esophageal fistula, pill dysphagia, pill swallowing phobia, food impaction, esophageal varices, coagulopathy, active anticoagulation or antithrombotics, active GI bleeding and pregnancy. Consecutive patients will be approached for consent until a total of 20 patients are enrolled. Patients will be approached during the same clinic visit if they meet inclusion criteria that arranges for the EGD or via telephone up to 2 weeks prior to scheduled EGD. Charts will be reviewed and patients will be asked medical and surgical history questions to assess if any exclusion criteria. Written consent will be obtained on the day of endoscopy. Charts will be reviewed and patients called at 1 week follow up to assess if any adverse events. EsoCheck Description The investigational product is called EsoCheck. EsoCheck is an encapsulated, inflatable, surface-textured balloon that is pill-sized (16x9mm) attached to a thin 2.16 mm silicone catheter. The device is swallowed with water. The catheter will be held without any tension to facilitate easy delivery to the stomach. The balloon is then inflated by injecting 5 cc of air through the catheter. This will be gently withdrawn until the tension from the esophageal sphincter is felt by the endoscopist. It is then pulled slowly to sample the esophagus. The balloon is then deflated while still in the distal esophagus using a syringe and inverted back into the capsule. EsoCheck Administration and Upper Endoscopy During the intervention period of the trial, patients will arrive early for their scheduled endoscopy. This involves swallowing the balloon device while unsedated. They will then undergo their previously scheduled endoscopy with standard biopsies taken as well as brush cytology performed as EsoCheck is a cytology device to best compare histology. EsoCheck and Brush Cytology Sample Processing and Handling: After retrieval of the capsule through the mouth, the balloon will be re-inflated, cut from the capsule at the junction of the balloon and the holding capsule. This will be immediately placed into a pre-labeled vial of Preservcyt transport medium. Vials will be stored on site in locked cabinets at room temperature. They will be shipped in small batches with de-identified patient study numbers and sent to the Cytology Department c/o Dr. Joseph Willis, University Hospitals Cleveland Medical Center. Specimens will be processed according to the standard operating procedures of the Department of Pathology at the University Hospitals Cleveland Medical Center. The vial containing the balloon is vortexed for 5 minutes, after which the balloon is then discarded. After centrifugation, the vial is then loaded onto the ThinPrep processor along with required assembly elements
- - including a pre-labeled slide corresponding to the received specimens.
Other: EoE patients
Patients will all be administered the EsoCheck device as a diagnostic test
Device: - EsoCheck
All patients with known diagnosis of EoE will be administered the EsoCheck device prior to standard of care endoscopy
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.