N/A
N=5,521
HALO Patient Registry: Ablation of Barrett's Esophagus
Barrett Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT00848237 ↗Enrolled (actual)
5,521
Serious AEs
0.4%
Results posted
Feb 2016
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiofrequency Ablation (HALO Ablation Systems) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up |
62.1 | — |
| PRIMARY Histological Clearance Rate for Intestinal Metaplasia (CE-IM) |
85.5 | — |
| PRIMARY Histological Clearance Rate for Dysplasia (CE-D) |
93.5 | — |
| PRIMARY Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up |
2.7 | — |
| PRIMARY Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month |
-2.7; -1.9; -2.8 | — |
| PRIMARY Adverse Event Incidence |
66 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00848237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.