Improving practicality of radiofrequency ablation for eradication of Barrett*s mucosa: a randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System

Improving practicality of radiofrequency ablation for eradication of Barrett*s mucosa: a randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System - Optimization of HALO90 ablation of Barrett's mucosa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35335

Enrollment

Registered

2009-04-03

Start date

2008-09-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia in Barrett's precancerous esophageal mucosa

Interventions

Eradication of Barrett's mucosa.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Scheduled HALO90 ablation for BE (with or without neoplasia) after prior circumferential ablation using the HALO360 System for BE with flat low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or for BE (with or without neoplasia) after prior endoscopic resection (ER) for lesions containing HGD or and early cancer. - One or more BE islands with a minimum size of 5-mm. - Written informed consent

Exclusion criteria

Exclusion criteria: Patients with endoscopically active inflammation in the treatment zone. - Esophageal stenosis preventing advancement of the endoscope with the HALO90 catheter. - Patients unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
Outcome parameters will be assessed after a single HALO90 treatment session: - Rate of complete removal of BE islets - Percentage of endoscopically visual surface regression of BE epithelium after 2 months as scored by two endoscopists blinded to the treatment regimen	—

Secondary

Measure	Time frame
non	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)