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A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus

Study acronym: ENDOBARRETT
StatusRecruiting
PhaseNot applicable
Started2022-03-25
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
Study Status, Outcome Measures, Contacts/Locations v4
Primary completion date2026-03→2031-07-25
Completion date2027-05→2031-07-25
Study sites12→17
Secondary endpoints15 entries, revised
Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by a doublean anatomical pathological reading on site, with centralised re-reading in the event of disagreement Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by a doublean anatomical pathological reading on site, with centralised re-reading in the event of disagreement Effectiveness assessment defined by the area regression of [...] al endoscopic scale of the area Barrett esophagus regression and video analysis Effectiveness asse [...] [...]
2024-04-08
Study Status, Eligibility v3
Primary completion date2025-02→2026-03
Completion date2026-05→2027-05
Eligibility criteria+9 characters
[...] t that cannot be stopped before the intervention (excluding 75100 mg maximum per day of aspirin in single-drug treatment) or any haemost [...]
2022-09-27
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-02→2025-02
Completion date2025-05→2026-05
Start dateestimated 2022-02→confirmed 2022-03-25
Secondary endpoints15 entries, revised
Effectiveness assessment defined by the rate of eradicatingBarretteradicating Barrett esophagus 12 months after the initial endoscopic treatment [...]
Study sitesdetails revised at 12 of 12 sites
2022-01-25
Study Status, Outcome Measures, Eligibility v1
Primary completion date2023-08→2024-02
Completion date2024-07→2025-05
Start date2021-05→2022-02
Eligibility criteria+124 characters
[...] th low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the [...] consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study. Exclusi [...] atment Presence of a visible lesion that is suspected to be early esophageal cancer or cancer provenconfirmed by biopsies Anterior resection of superficial or invasive carcinomaadenocarcinoma using endoscopic mucosal resection (EMR) or endo [...] [...]
Secondary endpoints15 entries, revised
[...] s of resected tissue enable the discovery of a dysplasia or carcinomaadenocarcinoma
2021-04-27
Original filing
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls. A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.
Trial Details
NCT Number NCT04867590
Lead Sponsor University Hospital, Angers
Conditions Barrett Esophagus, Dysplasia
Enrollment 140 participants
Start Date 2022-03-25
Primary Completion 2031-07-25 (estimated)
Study Completion 2031-07-25 (estimated)
Updated on ClinicalTrials.gov 2026-06-30