Clinical Trials

Cytosponge Protocol IRB 11-006429

Study Purpose

Whether the cytosponge will be a useful non-invasive tool in evaluating patients with eosinophilic esophagitis?

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

•Adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy.

Exclusion Criteria:

- Patients for whom clinically indicated endoscopy is not safe.

Patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule.

- Vulnerable populations, such as those with diminished mental acuity, will be excluded.

- Patients with known Lidocaine/Acetylcysteine allergies

Trial Details

Trial ID: 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.	NCT01585103
Phase 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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Katzka, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Cytosponge/ brushing

Interventions

Device: - Cytosponge - Brushing

Patients with eosinophilic esophagitis will be enrolled. Undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease. Two hours prior to endoscopy in the patients will be asked to swallow the Cytosponge. Briefly, the capsule and bunched up string are swallowed with water. The string is held without any tension to allow the capsule to move into the stomach. The patient holds onto the string for five minutes after ingestion to allow the capsule to dissolve in the proximal stomach, where a spherical mesh of 3 cm diameter is released. The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position. Following this, the clinically indicated endoscopy will be performed. Prior to biopsies we will do a brushing of the esophagus.

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.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Crystal J Lavey, CCRP

lavey.crystal@mayo.edu

507-538-1361

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