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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Covidien, GI Solutions
ClinicalTrials.gov Identifier:
NCT00489268
First received: June 19, 2007
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1 or 3 months. A complete response (CR) was defined as all biopsy specimens negative for Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the 2.5-year follow-up,the results of which were published . There is ample evidence that RFA for Barrett's esophagus is effective and safe. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA.


Condition Intervention
Barrett Esophagus
Device: HALO Ablation System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years

Resource links provided by NLM:


Further study details as provided by Covidien, GI Solutions:

Primary Outcome Measures:
  • Histological Clearance of Barrett's Metaplasia (Percent Patients) [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    The primary study outcomes were defined as the percent of patients with complete histological response to metaplasia or IM (CR-IM).


Secondary Outcome Measures:
  • Progression of Histological Grade [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Secondary outcomes of progression of histological grade was defined as proportion of participants had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis, the Kaplan-Meier survival curve shows the probability of maintaining CR-IM for at least 4 years after first durable CR-IM.

  • Adverse Events [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    The secondary outcome adverse events was defined as any event that occurred during the course of the trial that All adverse events and serious adverse events were recorded on a standardized case report form. Specifically, a stricture in this study was defined a priori as any narrowing of the esophageal lumen in the area of treatment causing symptoms or requiring dilation.

  • Sub-squamous Intestinal Metaplasia [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.


Enrollment: 102
Study Start Date: November 2003
Study Completion Date: October 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phase I: 6 J/cm2
Subjects randomized to the energy density group of 6 J/cm2
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
Other Names:
  • HALO360
  • HALO90
Active Comparator: Phase I: 8 J/cm2
Subjects randomized to the energy density group of 8 J/cm2
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
Other Names:
  • HALO360
  • HALO90
Active Comparator: Phase I: 10 J/cm2
Subjects randomized to the energy density group of 10 J/cm2
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
Other Names:
  • HALO360
  • HALO90
Active Comparator: Phase I: 12 J/cm2
Subjects randomized to the energy density group of 12 J/cm2
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
Other Names:
  • HALO360
  • HALO90
Active Comparator: Phase II
All Halo 360 treatments performed at 10 J/cm2; All Halo 90 treatments performed at 12 J/cm2
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
Other Names:
  • HALO360
  • HALO90

Detailed Description:

This study is intended to gather additional information regarding the performance of a bipolar balloon electrode device (HALO360) utilizing radiofrequency (RF) energy in the micro-layer ablation of Barrett's esophagus, a precancerous, metaplastic change in the esophageal lining. The device has received 510(k) clearance for specific indications, including the treatment of Barrett's esophagus.

This study is conducted in two phases and is intended to further evaluate the effect of micro-layer ablation of Barrett's metaplasia using a 510(k) cleared, bipolar, balloon electrode device. Phase I (n=30) is intended to provide additional information regarding the effects of three randomized treatment parameters (energy settings, Joules/cm2). Phase II (n=70) is intended to provide additional information regarding the effects of the optimal technique and energy density settings (Joules/cm2) determined from the 1-month endoscopy results of Phase I. Phase 2 primary endpoint was histological clearance of Barrett's (% patients). This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), at the 2.5-year follow-up, achieving a CR in 98.4% of patients. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA. This study will allow collection of 5-year follow-up biopsies and, thereafter, offer RFA for any subject with persistent Barrett's.

Upon approval of the present amendment to the protocol (B-200-5 year extension) and the informed consent form (ICF) at each study site, subjects who participated in B-200-2.5 year extension and had a biopsy at 2.5 years after initial enrollment will be offered participation in this extension.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has documented histopathological diagnosis of Barrett's metaplasia (without dysplasia) as follows:

    • biopsies obtained less than 6 months prior to enrollment, and
    • biopsies obtained and reviewed at the investigator institution, and
    • biopsy protocol included at least 4 quadrant biopsies per 2 cm length of Barrett's metaplasia
  2. Barrett metaplasia endoscopic length:

    Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive)

  3. Age 18-75 years inclusive
  4. Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
  5. Five year extension: All subjects who participated in B-200-2.5 year extension and had a biopsy at 2.5 years after initial enrollment (n=61) will be offered participation in this extension.

Exclusion Criteria:

  1. Subjects is pregnant or planning a pregnancy
  2. Esophageal stricture preventing passage of endoscope or catheter
  3. Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus
  4. Barrett's metaplasia with dysplasia (any previous biopsy)
  5. History or current diagnosis of malignancy of the esophagus
  6. Prior radiation therapy to the esophagus, except head and neck region radiation therapy
  7. Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other)
  8. Any previous endoscopic mucosal resection within the esophagus
  9. Any previous esophageal surgery, except fundoplication
  10. Esophageal varices
  11. Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
  12. Participation in another clinical study in past 60 days
  13. Subject suffers from unstable psychiatric disorder(s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489268

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Gastrointestinal Associates
Knoxville, Tennessee, United States, 37909
United States, Washington
Tacoma Digestive Disease and Research Center
Seattle, Washington, United States, 98405
Puerto Rico
Ponce Gastroenterology Research
Ponce, Puerto Rico, 00717
Sponsors and Collaborators
Covidien, GI Solutions
AstraZeneca
Investigators
Principal Investigator: David E Fleischer, MD Mayo Clinic
  More Information

Publications:
Responsible Party: David S. Utley, MD, BÂRRX Medical, Inc.
ClinicalTrials.gov Identifier: NCT00489268     History of Changes
Other Study ID Numbers: B-200
Study First Received: June 19, 2007
Results First Received: March 7, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien, GI Solutions:
Barrett's Esophagus
Intestinal Metaplasia
Radiofrequency Ablation

Additional relevant MeSH terms:
Barrett Esophagus
Metaplasia
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014