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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • Between the ages 18 - 90 years old;
    • With a BE segment ≥ 1cm in maximal extent endoscopically;
    • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia;
    • Undergoing clinically indicated endoscopy.
  • Subjects without known evidence of BE:
    • Undergoing clinically indicated diagnostic endoscopy.

Exclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • 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;
    • Patients with history of esophageal or gastric resection.
  • Subjects with or without known evidence of BE (on history or review of medical records):
    • Pregnant or lactating females;
    • Patients who are unable to consent;
    • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study);
    • History of eosinophilic esophagitis, achalasia;
    • Patients on oral anticoagulation including Coumadin, Warfarin;
    • Patients on antiplatelet agents including Clopidogrel, unless discontinued for at least three days prior to the sponge procedure.
    • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for at least three days prior to the sponge procedure.
    • Patients with history of known varices or cirrhosis.
    • Patients with history of esophageal or gastric resection;
    • Patients with congenital or acquired bleeding diatheses;
    • Patients with a history of esophageal squamous dysplasia.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prasad Iyer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Herbert Wolfsen, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Francisco Ramirez, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Austin, Minn.

Mayo Clinic principal investigator

Prasad Iyer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20167659

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