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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03311451
Eligibility Criteria:
Inclusion Criteria:
1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
* Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR
* Residual BE with any grade of dysplasia 6 weeks after endoscopic resection
2. Prague Classification Score C≤3 and ≥M1
3. Patients should be ablation-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. Patient provides written informed consent on the IRB-approved informed consent form
7. Patient is willing and able to comply with follow-up requirements.
Exclusion Criteria:
1. Esophageal stenosis preventing advancement of a therapeutic endoscope
2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER \>6 weeks prior to planned treatment under this protocol.
3. Prior ER of more than 2cm in length or \>50% of the esophageal lumen circumference
4. History of locally advanced (\>SM1) esophageal cancer
5. History of esophageal varices
6. Prior distal esophagectomy
7. Active esophagitis LA grade B or higher
8. Severe medical comorbidities precluding endoscopy
9. Uncontrolled coagulopathy
10. Pregnant or planning to become pregnant during period of study
11. Patient refuses or is unable to provide written informed consent
12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study
13. 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:
NCT03311451
Study Brief:
Protocol Section:
NCT03311451