CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,521 enrolled
Drug / intervention
Radiofrequency Ablation (HALO Ablation Systems)device
Likely dose
Radiofrequency ablation via HALO Ablation System (circumferential or focal procedures) plus proton pump inhibitor therapyAI-extracted
Key inclusion· 2
  • Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System
  • Must agree to proposed follow-up schedule and provide informed consent
Key exclusion· 4
  • Pregnancy
  • Prior radiation therapy to the esophagus
  • Esophageal varices at risk for bleeding
  • Prior Heller Myotomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00848237
NCT00848237N/ACompleted

HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry

Medtronic - MITG·interventional·Posted Feb 20, 2009·Updated Feb 5, 2016

In Brief

A clinical study evaluating Radiofrequency Ablation (HALO Ablation Systems) for Barrett Esophagus. Completed, enrolled 5,521 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2009
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 17.4 years ago

Interventions

Radiofrequency Ablation (HALO Ablation Systems)device

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.