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Clinical Trials/NL-OMON21516
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

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
AMC Amsterdam

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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