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N/A
18 Years
N/A
Not Enrolling
Both
Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma

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Trial Information


Inclusion Criteria:



- Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High
Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.

- Undergoing any type of endoscopic BE ablation treatment

- <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.

- Age > 18 years

- Ability to provide written, informed consent

Exclusion Criteria:

- Participation in another clinical study

- Circumferential BE

- Complete eradication of BE documented by biopsies

- Inability to obtain biopsies due to anticoagulation, varices, etc.

- Allergy to fluorescein

- Pregnancy

- Renal insufficiency

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Composite outcome of "optimally treated" BE patients in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.

Outcome Time Frame:

3 month follow-up endoscopic procedure

Safety Issue:

No

Principal Investigator

Michael Wallace, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic Jacksonville, Florida, United States

Authority:

United States: Institutional Review Board

Study ID:

MKT-2009-BE-01

NCT ID:

NCT01032044

Start Date:

February 2010

Completion Date:

April 2011

Related Keywords:

  • Barrett Syndrome
  • Barrett's Syndrome
  • Barrett's Esophagus
  • Barrett Esophagus
  • Adenocarcinoma
  • Barrett's esophagus
  • EsoGastroDuodenoscopy
  • Barrett's carcinoma
  • adenocarcinoma
  • Cellvizio
  • endomicroscopy
  • probe-based Confocal Laser Endomicroscopy
  • pCLE
  • Radio-frequency ablation
  • Endoscopic mucosal resection
  • Photodynamic therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus

Name

Location
University of Washington Medical Center Seattle, Washington  98195-6043
Mayo Clinic Jacksonville, Florida  32224
University of Chicago Hospital Chicago, Illinois  60637-1470
Veterans Affairs Hospital Kansas City, Missouri  64128