Ensayos clínicos

Inclusion Criteria

1. Diagnosis of non-dysplastic, LGD, or indefinite for dysplasia BE (confirmed by baseline histopathological analysis) that is non-nodular and previously untreated (“treatment naïve”).  Endoscopic mucosal resection (EMR) may be done to treat visible BE ≥6 weeks prior to enrolling the patient to this study.
2. BE lesion length ≤3cm
3. Prague Classification Score C>2 / M>2
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/EC-approved informed consent form
7. Willing and able to comply with follow-up requirements

Exclusion Criteria

1. High-grade dysplastic (HGD) Barrett’s Epithelium, or intramucosal cancer (ImCA)
2. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.  Patient may have the stenosis or stricture dilated and then be treated with the CryoBalloon Full under this protocol at a subsequent procedure ≥2 weeks later.
3. Symptomatic untreated stricture
4. Any endoscopically visualized lesion such as ulcers, masses or nodules.  Neoplastic nodules must first be treated with EMR >6 weeks prior to planned treatment under this protocol.
5. Prior EMR >2cm in length and >50% of the esophageal lumen circumference
6. History of esophageal cancer
7. History of esophageal varices
8. Prior distal esophagectomy
9. Active esophagitis LA grade B or higher (patient may have esophagitis treated and then have CryoBalloon Full ablation under this protocol at a subsequent procedure >2 weeks later)
10. Severe medical comorbidities precluding endoscopy
11. Uncontrolled coagulopathy
12. Pregnant or planning to become pregnant during period of study
13. Patient refuses or is unable to provide written informed consent
14. Life expectancy ≤2 years, as judged by the site investigator
15.  General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation