Clinical trial · Observational
Cryotherapy -BEATS-RF Ablation Trial
CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
NCT01882478CI-TRIAL-00054576completedClinicalTrials.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 purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
Conditions
Conditions (2)
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 With Persistent Dysplasia or | — | UNRESOLVED | — |
| Early Esophageal Adenocarcinoma Post Radio Frequency Ablation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- failure to respond to RF ablation
- description
- patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions
Primary outcomes (1)
- measure
- Response
- timeFrame
- 2 years
- description
- To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA
Secondary outcomes (1)
- measure
- Predictors of response
- timeFrame
- 2 years
- description
- To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * Able to provide informed consent * Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy. * Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR * Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment Exclusion Criteria: * Age younger than 18 years old * Life expectancy less than 12 months * Pregnancy * Presence of esophageal varices * Esophageal stricture precluding passage of an endoscope and suction tubing * Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease) * Esophageal cancer (T2 and above)
References
Publications (0)
Data not yet available
No reference posted for this study.