NCT00489268

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 30, 2011

Completed
Last Updated

March 13, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

June 19, 2007

Results QC Date

March 7, 2011

Last Update Submit

January 31, 2017

Conditions

Barrett Esophagus

Keywords

Barrett's EsophagusIntestinal MetaplasiaRadiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • 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).

    5 year

Secondary Outcomes (3)

  • Progression of Histological Grade

    5 year

  • Adverse Events

    5 year

  • Percentage of Participants With Sub-squamous Intestinal Metaplasia

    5 year

Study Arms (5)

Phase I: 6 J/cm2

ACTIVE COMPARATOR

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

Device: HALO Ablation System

Phase I: 8 J/cm2

ACTIVE COMPARATOR

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

Device: HALO Ablation System

Phase I: 10 J/cm2

ACTIVE COMPARATOR

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

Device: HALO Ablation System

Phase I: 12 J/cm2

ACTIVE COMPARATOR

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

Device: HALO Ablation System

Phase II

ACTIVE COMPARATOR

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.

Device: HALO Ablation System

Interventions

HALO Ablation SystemDEVICE

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.

Also known as: HALO360, HALO90
Phase I: 10 J/cm2Phase I: 12 J/cm2Phase I: 6 J/cm2Phase I: 8 J/cm2Phase II

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Gastrointestinal Associates

Knoxville, Tennessee, 37909, United States

Location

Tacoma Digestive Disease and Research Center

Seattle, Washington, 98405, United States

Location

Ponce Gastroenterology Research

Ponce, 00717, Puerto Rico

Location

Related Publications (3)

  • 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.

    PMID: 17258973RESULT

  • 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.

    PMID: 18561930RESULT

  • 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.

    PMID: 20857372RESULT

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Limitations and Caveats

Study had no concurrent control arm, biopsy forceps were not standardized for all cases, the original patient group comprised 70 patients, whereas 69 and 61 patients were available at 1 and 2.5 years, respectively, 60 eligible patients at 5 years.

Results Point of Contact

Title
David E. Fleischer, M.D.
Organization
Mayo Clinic, Arizona
fleischer.david@mayo.edu
(480) 301-4461

Study Officials

  • David E Fleischer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

November 1, 2003

Primary Completion

February 1, 2007

Study Completion

October 1, 2009

Last Updated

March 13, 2017

Results First Posted

June 30, 2011

Record last verified: 2017-01

Locations

US(9)PR(1)