Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT03120195
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Age equal to or above 18 years (adult).
* Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
* Scheduled Barrett's ablation for:
* Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
* Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR \<50% of the circumference)
* Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.
Exclusion Criteria:
* Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
* In case of previous EMR: EMR specimen showing deep submucosal invasion (\> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
* In case of previous EMR: \> 50% circumference.
* Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
* Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
* Evidence of portal hypertension, esophageal varices, etc.
* An interval \< 6 weeks between EMR and EndoRotor treatment.
* An interval of \> 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
* Unable to undergo endoscopic procedure using sedation analgesics.
* Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03120195
Study Brief:
Protocol Section:
NCT03120195