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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT03097666
Eligibility Criteria:
Inclusion Criteria:
1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
* Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
* Residual BE with any grade of dysplasia after endoscopic resection
2. Prague Classification Score C≤3
3. Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
4. Older than 18 years of age at time of consent
5. Operable per institution's standards
6. Provides written informed consent on the IRB-approved informed consent form
7. Willing and able to comply with follow-up requirements
Exclusion Criteria:
1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
2. Any endoscopically visualized lesion such as ulcers, masses or nodules.
3. History of locally advanced (\>T1a) esophageal cancer
4. History of esophageal varices
5. Prior distal esophagectomy
6. Active esophagitis LA grade B or higher
7. Severe medical comorbidities precluding endoscopy
8. Uncontrolled coagulopathy
9. Pregnant or planning to become pregnant during period of study
10. Patient refuses or is unable to provide written informed consent
11. Participation in another study with investigational drug within the 30 days preceding or during the present study
12. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03097666
Study Brief:
Protocol Section:
NCT03097666