Cytosponge Protocol IRB 11-006429

Mayo Clinic

Status: Terminated

Conditions: Eosinophilic Esophagitis

Treatments: Device: Cytosponge

Study type: Interventional

Funder types: Other

Identifiers

NCT01585103

11-006429

Details and patient eligibility

About

This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

86 participants in 1 patient group

Cytosponge/ brushing

Experimental group

Description:

Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.

Treatment:

Device: Cytosponge