Clinical trial · Interventional
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma
Prospective Randomized Trial Comparing Radiofrequency Ablation and Cryotherapy for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma
NCT01961778CI-TRIAL-00055920completedN/AClinicalTrials.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)
Prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.
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's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Device | — | UNRESOLVED |
| Radio-Frequency Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radio-Frequency Ablation
- description
- Patients in this arm will receive treatment with radio-frequency ablation.
- interventionNames
- Device: Radio-Frequency Ablation
- type
- ACTIVE_COMPARATOR
- label
- Cryothearpy
- description
- Patients in this arm will receive treatment with cryotherapy.
- interventionNames
- Device: Cryotherapy
Primary outcomes (1)
- measure
- Percentage of Barrett's esophagus ablated during the initial treatment session.
- timeFrame
- 2-3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus Exclusion Criteria: * contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) * refusal to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.