Clinical trial · Interventional
Radiofrequency Ablation for the Treatment of Gastric Dysplasia
Ablation of Gastric Dysplastic Mucosa by a Novel Endoscopic Radiofrequency Device.
- 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 finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.
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 |
|---|---|---|---|
| Gastric Dysplasia | — | UNRESOLVED | — |
| Neoplasia | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation of dysplastic mucosa (HALO) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gastric RFA
- description
- Ablation of gastric dysplastic mucosa
- interventionNames
- Device: Radiofrequency ablation of dysplastic mucosa (HALO)
Primary outcomes (1)
- measure
- The % of patients with complete histological clearance of dysplasia.
- timeFrame
- 12 months
Secondary outcomes (2)
- measure
- Histological clearance of intestinal metaplasia
- timeFrame
- 12 months
- measure
- Adverse event incidence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological confirmation of gastric dysplasia. 2. The lesion is no larger than 5 cm in diameter. 3. Age ≥ 18 years. 4. Subject is able to tolerate endoscopy and sedation. 5. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form. Exclusion Criteria: 1. Prior gastric irradiation or surgery. 2. Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA. 3. Gastric ulcers, fistulae, varices and malignancy. 4. History of alcohol and/or controlled substance dependency. 5. Pregnancy.
References
Publications (0)
Data not yet available