Barrett Esophagus
Conditions
Keywords
Barrett's Esophagus, Dysplasia, Intestinal Metaplasia
Brief summary
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.
Detailed description
Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems. Protocol Design: This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms on-line. Retrospective data collection is defined as any data other than patient history collected prior to signing of the informed consent. A set of case report forms (CRFs) is provided along with this protocol to track outcomes. The CRFs may be completed and retained on site, but the site is recommended to utilize the internet-based data entry system.
Interventions
DEVICERadiofrequency Ablation (HALO Ablation Systems)
Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System. * Must agree to the proposed follow-up schedule and provide informed consent for participation.
Exclusion criteria
* Pregnancy * Prior radiation therapy to the esophagus * Esophageal varices at risk for bleeding * Prior Heller Myotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up | 1 year | % of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies. |
| Histological Clearance Rate for Intestinal Metaplasia (CE-IM) | 1 year | Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up |
| Histological Clearance Rate for Dysplasia (CE-D) | 1 year | percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up |
| Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up | 1 year | Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface |
| Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | 12 month | Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry). |
| Adverse Event Incidence | 12 month | Adverse and Serious Adverse event with Definite device relationship |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. | 5,521 |
| Total | 5,521 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 1 participants |
| Age, Categorical >=65 years | 2279 participants |
| Age, Categorical Between 18 and 65 years | 3235 participants |
| Age, Continuous | 61.6 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 5521 participants |
| Sex: Female, Male Female | 1469 Participants |
| Sex: Female, Male Male | 4052 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 5,521 |
| serious Total, serious adverse events | 24 / 5,521 |
Outcome results
Primary
Adverse Event Incidence
Adverse and Serious Adverse event with Definite device relationship
Time frame: 12 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Adverse Event Incidence | 66 participants |
Primary
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
Time frame: 1 year
Population: 4011 subjects provided the answers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up | 62.1 percentage of participants |
Primary
Histological Clearance Rate for Dysplasia (CE-D)
percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Time frame: 1 year
Population: 4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Histological Clearance Rate for Dysplasia (CE-D) | 93.5 percentage of participants |
Primary
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Time frame: 1 year
Population: 4118 provided biopsies at least 1 year post RFA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Histological Clearance Rate for Intestinal Metaplasia (CE-IM) | 85.5 percentage of participants |
Primary
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).
Time frame: 12 month
Population: 943 subjects completed both baseline and follow up quality of life life survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | Changes:concern about the condition of esophagus | -2.7 units on a scale | Standard Deviation 3.2 |
| Treatment | Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | Negative impact on life | -1.9 units on a scale | Standard Deviation 3 |
| Treatment | Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | Esophageal cancer worry | -2.8 units on a scale | Standard Deviation 3.4 |
Primary
Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up | 2.7 percentage of patients with SSIM |