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

NCT ID: NCT00489268

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2009-10-31

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.

Conditions

Barrett Esophagus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I: 6 J/cm2

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

Group Type: ACTIVE_COMPARATOR

HALO Ablation System

Intervention Type: DEVICE

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.

Phase I: 8 J/cm2

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

Group Type: ACTIVE_COMPARATOR

HALO Ablation System

Intervention Type: DEVICE

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.

Phase I: 10 J/cm2

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

Group Type: ACTIVE_COMPARATOR

HALO Ablation System

Intervention Type: DEVICE

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.

Phase I: 12 J/cm2

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

Group Type: ACTIVE_COMPARATOR

HALO Ablation System

Intervention Type: DEVICE

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.

Phase II

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.

Group Type: ACTIVE_COMPARATOR

HALO Ablation System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

HALO360; HALO90

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Covidien, GI Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

BÂRRX Medical, Inc.

Principal Investigators

David E Fleischer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

UC Irvine Medical Center

Orange, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

Oregon Health Sciences University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Gastrointestinal Associates

Knoxville, Tennessee, United States

Tacoma Digestive Disease and Research Center

Seattle, Washington, United States

Ponce Gastroenterology Research

Ponce, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: RESULT

PMID: 17258973 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18561930 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20857372 (View on PubMed)

Other Identifiers

B-200

Identifier Type: -

Identifier Source: org_study_id