Clinical trial · Interventional
HALO Patient Registry: Ablation of Barrett's Esophagus
HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
NCT00848237CI-TRIAL-00020816completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency Ablation (HALO Ablation Systems) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
- interventionNames
- Device: Radiofrequency Ablation (HALO Ablation Systems)
Primary outcomes (6)
- measure
- Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
- timeFrame
- 1 year
- description
- % 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.
- measure
- Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- RESULTShaheen NJ, Kim HP, Bulsiewicz WJ, Lyday WD, Triadafilopoulos G, Wolfsen HC, Komanduri S, Chmielewski GW, Ertan A, Corbett FS, Camara DS, Rothstein RI, Overholt BF. Prior fundoplication does not improve safety or efficacy outcomes of radiofrequency ablation: results from the U.S. RFA Registry. J Gastrointest Surg. 2013 Jan;17(1):21-8; discussion p.28-9. doi: 10.1007/s11605-012-2001-8. Epub 2012 Sep 11. PMID 22965650