NL-OMON21516
Recruiting
Not Applicable
Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing three different treatment regimens for circumferential ablation using the HALO360 System.
AMC Amsterdam0 sites60 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett's esophagus
- Sponsor
- AMC Amsterdam
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Scheduled HALO360 ablation 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;
- •2\. Review of histopathology specimens by a local expert pathologist;
Exclusion Criteria
- •1\. In case of prior ER: A specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (≥ T1sm2\), poorly or undifferentiated cancer (G3 or G4\), or lymphatic/vascular invasion;
- •2\. Patients unable to give informed consent.
Outcomes
Primary Outcomes
Not specified
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