Actively Recruiting
Comparing EndoRotor Device and Radiofrequency Treatment for Barretts Esophagus with Dysplasia
Led by University Hospital, Angers · Updated on 2026-06-30
140
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Barrett Esophagus is a condition where the esophageal lining changes, increasing the risk of developing precancerous tissue and adenocarcinoma. This study compares two treatment methods for Barrett Esophagus complicated by dysplasia the new EndoRotor system versus the established Radiofrequency ablation. The aim is to evaluate the effectiveness of these treatments in eradicating Barrett Esophagus and associated dysplasia. The study is randomized and controlled, conducted by the University Hospital, Angers. The EndoRotor system mechanically removes the esophageal mucosa in one session through a device that cuts and aspirates tissue, allowing for histological analysis after treatment. Radiofrequency ablation uses thermal energy to destroy the abnormal mucosa, typically requiring multiple sessions with a debridement step using acetylcysteine spray before ablation. Participants are randomly assigned to receive either EndoRotor or Radiofrequency treatment. Both methods aim to fully eradicate Barrett Esophagus tissue but differ in technique and potential costs. Participants will undergo endoscopic evaluations before and after treatment, with biopsies taken to assess the presence of Barrett Esophagus and dysplasia at 3 and 12 months post-treatment. Safety assessments include monitoring discomfort, pain, and adverse events for up to 3 months. The study also evaluates the quality of tissue samples for pathological analysis, treatment cost-effectiveness, and the number of additional treatment sessions needed. Total participation may last up to a year, with multiple follow-up visits to monitor treatment success and safety.
CONDITIONS
Brief Title
A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with Barrett's esophagus measuring 2 to 6 cm in the longest tongue and low to high grade dysplasia or superficial non-invasive adenocarcinoma confirmed by histology
- Total Barrett's esophagus height evaluated by Prague classification with circumferential segment between 0 and 6 cm and longest tongue between 2 and 6 cm
- Signed consent form to participate in the study
- Pre-inclusion allowed before histological confirmation of dysplasia or adenocarcinoma
You will not qualify if you...
- Individuals over 85 years old
- Pregnant, breastfeeding, or laboring women
- Individuals in detention by judicial or administrative decision
- Individuals under psychiatric treatment against their will
- Those under legal protection measures
- Individuals unable to give informed consent
- Individuals who do not understand or read French
- Those without social security coverage or benefits
- Active peptic, radiation-induced, or complicated esophagitis at treatment time
- Presence of visible suspected esophageal cancer lesions
- Prior invasive adenocarcinoma resections with certain invasion characteristics
- Previous ablation treatments or dilation for esophageal stenosis
- Significant esophageal stenosis preventing gastroscope passage
- Presence of esophageal varices or portal hypertension
- Anticoagulant treatment that cannot be stopped (except low-dose aspirin)
- Contraindication to anesthesia
- Inability to take proton pump inhibitors orally
Research Team
E
Elodie CESBRON-METIVIER, Ph.D.
D
DRCI CHU Angers
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