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

Primary Purpose

Barrett Esophagus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HALO Ablation System
Sponsored by
Covidien, GI Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett Esophagus focused on measuring Barrett's Esophagus, Intestinal Metaplasia, Radiofrequency Ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic Scottsdale
  • UC Irvine Medical Center
  • Beth Israel Deaconess Medical Center
  • Mayo Clinic Rochester
  • Columbia University Medical Center
  • Oregon Health Sciences University
  • University of Pennsylvania
  • Gastrointestinal Associates
  • Tacoma Digestive Disease and Research Center
  • Ponce Gastroenterology Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Phase I: 6 J/cm2

Phase I: 8 J/cm2

Phase I: 10 J/cm2

Phase I: 12 J/cm2

Phase II

Arm Description

Subjects randomized to the energy density group of 6 J/cm2 through the HALO Ablation System.

Subjects randomized to the energy density group of 8 J/cm2 through the HALO Ablation System.

Subjects randomized to the energy density group of 10 J/cm2 through the HALO Ablation System.

Subjects randomized to the energy density group of 12 J/cm2 through the HALO Ablation System.

All Halo 360 treatments performed at 10 J/cm2 through the HALO Ablation System. All Halo 90 treatments performed at 12 J/cm2 through the HALO Ablation System.

Outcomes

Primary Outcome Measures

Percentage of Participants With Histological Clearance of Barrett's Metaplasia
The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).

Secondary Outcome Measures

Progression of Histological Grade
Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.
Adverse Events
The secondary outcome adverse events was defined as any event that occurred during the course of the trial
Percentage of Participants With Sub-squamous Intestinal Metaplasia
The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.

Full Information

First Posted
June 19, 2007
Last Updated
January 31, 2017
Sponsor
Covidien, GI Solutions
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00489268
Brief Title
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
Acronym
AIM
Official Title
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Covidien, GI Solutions
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Esophagogastroduodenoscopy (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 RadioFrequency Ablation (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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
Keywords
Barrett's Esophagus, Intestinal Metaplasia, Radiofrequency Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I: 6 J/cm2
Arm Type
Active Comparator
Arm Description
Subjects randomized to the energy density group of 6 J/cm2 through the HALO Ablation System.
Arm Title
Phase I: 8 J/cm2
Arm Type
Active Comparator
Arm Description
Subjects randomized to the energy density group of 8 J/cm2 through the HALO Ablation System.
Arm Title
Phase I: 10 J/cm2
Arm Type
Active Comparator
Arm Description
Subjects randomized to the energy density group of 10 J/cm2 through the HALO Ablation System.
Arm Title
Phase I: 12 J/cm2
Arm Type
Active Comparator
Arm Description
Subjects randomized to the energy density group of 12 J/cm2 through the HALO Ablation System.
Arm Title
Phase II
Arm Type
Active Comparator
Arm Description
All Halo 360 treatments performed at 10 J/cm2 through the HALO Ablation System. All Halo 90 treatments performed at 12 J/cm2 through the HALO Ablation System.
Intervention Type
Device
Intervention Name(s)
HALO Ablation System
Other Intervention Name(s)
HALO360, HALO90
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Histological Clearance of Barrett's Metaplasia
Description
The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Progression of Histological Grade
Description
Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.
Time Frame
5 year
Title
Adverse Events
Description
The secondary outcome adverse events was defined as any event that occurred during the course of the trial
Time Frame
5 year
Title
Percentage of Participants With Sub-squamous Intestinal Metaplasia
Description
The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Barrett metaplasia endoscopic length: Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive) Age 18-75 years inclusive Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form 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: Subjects is pregnant or planning a pregnancy Esophageal stricture preventing passage of endoscope or catheter Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus Barrett's metaplasia with dysplasia (any previous biopsy) History or current diagnosis of malignancy of the esophagus Prior radiation therapy to the esophagus, except head and neck region radiation therapy Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) Any previous endoscopic mucosal resection within the esophagus Any previous esophageal surgery, except fundoplication Esophageal varices 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 Participation in another clinical study in past 60 days Subject suffers from unstable psychiatric disorder(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Fleischer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Gastrointestinal Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Tacoma Digestive Disease and Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Ponce Gastroenterology Research
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17258973
Citation
Sharma VK, Wang KK, Overholt BF, Lightdale CJ, Fennerty MB, Dean PJ, Pleskow DK, Chuttani R, Reymunde A, Santiago N, Chang KJ, Kimmey MB, Fleischer DE. Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients. Gastrointest Endosc. 2007 Feb;65(2):185-95. doi: 10.1016/j.gie.2006.09.033.
Results Reference
result
PubMed Identifier
18561930
Citation
Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up. Gastrointest Endosc. 2008 Nov;68(5):867-76. doi: 10.1016/j.gie.2008.03.008. Epub 2008 Jun 17.
Results Reference
result
PubMed Identifier
20857372
Citation
Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Muthasamy R, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20.
Results Reference
result

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

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