Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years

NACompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

February 28, 2007

Study Completion Date

October 31, 2009

Conditions
Barrett Esophagus
Interventions
DEVICE

HALO Ablation System

"Phase I: 1-2 ablation visits; Phase II 1 to 12 months: 1-2 ablation visits; Phase II 12 to 30 months: 1-3 ablation visits Phase II 55-60 months: 0-1 ablation visit~\*\*\*\*\*\*Phase I was a dosimetry study and Phase II used the preferred dose. The same intervention was used for each dose."

Trial Locations (10)

10032

Columbia University Medical Center, New York

19104

University of Pennsylvania, Philadelphia

37909

Gastrointestinal Associates, Knoxville

55905

Mayo Clinic Rochester, Rochester

85259

Mayo Clinic Scottsdale, Scottsdale

92868

UC Irvine Medical Center, Orange

97239

Oregon Health Sciences University, Portland

98405

Tacoma Digestive Disease and Research Center, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

00717

Ponce Gastroenterology Research, Ponce

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Covidien, GI Solutions

INDUSTRY