Trial Outcomes & Findings for Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years (NCT NCT00489268)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

5 year

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: 6 J/cm^2 The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. They received a dose of 6 J/cm\^2 during the course of this study.	Phase I: 8 J/cm^2 In this group, subjects were randomized to the energy density group of 8 J/cm\^2. They received a dose of 8 J/cm\^2 during the course of this study.	Phase I: 10 J/cm^2 In this group, subjects were randomized to the energy density group of 10 J/cm\^2. They received a dose of 10 J/cm\^2 during the course of this study.	Phase I: 12 J/cm^2 In this group, subjects were randomized to the energy density group of 12 J/cm\^2. They received a dose of 12 J/cm\^2 during the course of this study.	Phase II In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2
Overall Study STARTED	1	10	10	11	70
Overall Study COMPLETED	1	10	9	11	50
Overall Study NOT COMPLETED	0	0	1	0	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: 6 J/cm^2 n=1 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. They received a dose of 6 J/cm\^2 during the course of this study.	Phase I: 8 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm\^2. They received a dose of 8 J/cm\^2 during the course of this study.	Phase I: 10 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm\^2. They received a dose of 10 J/cm\^2 during the course of this study.	Phase I: 12 J/cm^2 n=11 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm\^2. They received a dose of 12 J/cm\^2 during the course of this study.	Phase II n=70 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	54 Participants n=21 Participants	80 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants	22 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants	21 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	52 Participants n=21 Participants	81 Participants n=10 Participants
Region of Enrollment United States	1 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	11 participants n=4 Participants	52 participants n=21 Participants	84 participants n=10 Participants
Region of Enrollment Puerto Rico	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	18 participants n=21 Participants	18 participants n=10 Participants

PRIMARY outcome

Timeframe: 5 year

Population: The analysis was done per protocol.

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).

Outcome measures

Outcome measures
Measure	Phase I: 6 J/cm^2 n=1 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. They received a dose of 6 J/cm\^2 during the course of this study.	Phase I: 8 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm\^2. They received a dose of 8 J/cm\^2 during the course of this study.	Phase I: 10 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm\^2. They received a dose of 10 J/cm\^2 during the course of this study.	Phase I: 12 J/cm^2 n=11 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm\^2. They received a dose of 12 J/cm\^2 during the course of this study.	Phase II n=70 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2
Percentage of Participants With Histological Clearance of Barrett's Metaplasia	100 Percent of Participants	20 Percent of Participants	78 Percent of Participants	82 Percent of Participants	92 Percent of Participants

SECONDARY outcome

Timeframe: 5 year

Population: The analysis was done per protocol.

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.

Outcome measures

Outcome measures
Measure	Phase I: 6 J/cm^2 n=1 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. They received a dose of 6 J/cm\^2 during the course of this study.	Phase I: 8 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm\^2. They received a dose of 8 J/cm\^2 during the course of this study.	Phase I: 10 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm\^2. They received a dose of 10 J/cm\^2 during the course of this study.	Phase I: 12 J/cm^2 n=11 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm\^2. They received a dose of 12 J/cm\^2 during the course of this study.	Phase II n=70 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2
Progression of Histological Grade	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants

SECONDARY outcome

Timeframe: 5 year

Population: The analysis was done per protocol.

The secondary outcome adverse events was defined as any event that occurred during the course of the trial

Outcome measures

Outcome measures
Measure	Phase I: 6 J/cm^2 n=1 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. They received a dose of 6 J/cm\^2 during the course of this study.	Phase I: 8 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm\^2. They received a dose of 8 J/cm\^2 during the course of this study.	Phase I: 10 J/cm^2 n=10 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm\^2. They received a dose of 10 J/cm\^2 during the course of this study.	Phase I: 12 J/cm^2 n=11 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm\^2. They received a dose of 12 J/cm\^2 during the course of this study.	Phase II n=70 Participants The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2
Adverse Events	0 Participants	0 Participants	7 Participants	0 Participants	28 Participants

SECONDARY outcome

Timeframe: 5 year

Population: The analysis was done per protocol.

The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.