Clinical trial · Interventional
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
- 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)
This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.
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 |
|---|---|---|---|
| Barretts Esophagus | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryospray Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Barrett's Esophagus with intramucosal carcinoma (IMCA)
- interventionNames
- Procedure: Cryospray Ablation
- type
- EXPERIMENTAL
- label
- Barrett's Esophagus with High Grade Dysplasia (HGD)
- interventionNames
- Procedure: Cryospray Ablation
Primary outcomes (2)
- measure
- Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
- timeFrame
- at 12 months from start of treatment
- description
- Determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Group 1: * Co-morbid conditions such as severe heart, lung, kidney or liver disease. * Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy. Group 2: * Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall Exclusion Criteria: * Age less than 18 years * Co-morbid illness expected to cause death within 6 months * Pregnancy * Refusal or inability to give consent
References
Publications (0)
Data not yet available