Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:1/9/2019
Start Date:October 2015
End Date:December 2019
Contact:Michele L Johnson, CCRP
Email:johnson.michele@mayo.edu
Phone:507-293-5307

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Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

This study will evaluate if the capsule sponge device can detect the presence of Barrett's
Esophagus

Assess the sensitivity and specificity of a panel of DNA methylation markers in the
non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a
capsule sponge device.

Inclusion criteria:

Subjects with known Barrett's Esophagus (BE).

1. Patient between the ages 18 - 85.

2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically.

3. Histology showing evidence of intestinal metaplasia with or without presence of
dysplasia.

4. Undergoing clinically indicated endoscopy.

Subjects without known evidence of BE

1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria:

Subjects with known BE.

1. Patients with prior history of ablation (photodynamic therapy, radiofrequency
ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic
mucosal resection alone will not be excluded.

2. Patients with history of esophageal or gastric resection.

Subjects with or without known evidence of BE (on history or review of medical records).

1. Pregnant or lactating females.

2. Patients who are unable to consent.

3. Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated
dysphagia.

4. Patients on oral anticoagulation including Coumadin, Warfarin.

5. Patients on antiplatelet agents including Clopidogrel, unless discontinued for 5 days
prior to the sponge procedure.

6. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a
inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 5 days
prior to the sponge procedure.

7. Patients with history of known varices or cirrhosis.

8. Patients with history of esophageal or gastric resection.

9. Patients with congenital or acquired bleeding diatheses.

10. Patients with a history of esophageal squamous dysplasia.
We found this trial at
3
sites
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-255-8692
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Jacksonville, Florida 32216
Phone: 904-953-2255
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Rochester, Minnesota 55905
Principal Investigator: Prasad G Iyer, MD
Phone: 507-293-5307
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