Endorotor Resection In Refractory Barrett's Dysplasia Patients

This is a prospective, multi-center, randomized study to compare the safety and performance
of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with
refractory dysplastic Barrett's Esophagus. Subjects must have failed 3 RFA treatments
(failure of Barrett's to respond to RFA with a decrease of at least 50% of its length) and
following 3 RFA failures have no endoscopic and histologic evidence of esophageal
adenocarcinoma at the time of therapy. The subjects are randomized and treated (up to 2
times) with either the EndoRotor® which resects the affected mucosa and submucosa (down to
the muscularis propria layer), or with cryotherapy or ablative therapy of the persistent
lesions. Subjects will be followed with biopsies of the resected areas at the time of
surveillance endoscopies every 3 months until they have 2 consecutive negative endoscopies
and biopsies (6 months).

The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic
mucosal resection system for use in the gastrointestinal tract for benign neoplastic or
pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The
EndoRotor® System performs both tissue dissection and resection with a single device through
an endoscope's instrument biopsy channel.

Inclusion Criteria:

1. Subjects who are >30 and <79 years of age; inclusive of males and females.

2. Subjects with a history of confirmed Barrett's esophagus with dysplasia (low-grade or
high-grade) refractory to radiofrequency ablation 3 times.

3. Residual Barrett's length is ≥1 cm and ≤6 cm.

4. Histologic persistence of intestinal metaplasia (any non-squamous epithelial lesion)
following treatment and failed eradication.

5. Following 3 failed RFA procedures with no confirmed evidence of EAC and having
confirmed no endoscopic and histologic evidence of EAC at the time of therapy.

6. Subject capable of giving informed consent.

7. Subject has a reasonable expectation for prolonged survival (greater than 5 years).

8. Subject can tolerate repeated endoscopic procedures.

9. Absence of strictures that preclude the passage of the endoscope.

10. Subjects with the ability to understand the requirements of the study, who have
provided written informed consent, and who are willing and able to return for the
required follow-up assessments

Exclusion Criteria:

1. Subject unable to give informed consent.

2. Subject is unwilling to return for repeated endoscopies.

3. Subject having 3 failed RFA procedures and confirmed endoscopic and histologic
evidence of EAC at time of therapy.

4. Residual Barrett's longer than 6 cm.

5. Subjects with nodular Barrett's Esophagus.

6. Subjects who are on aspirin or anticoagulant therapy who cannot stop it and have had
bleeding problems during previous endoscopic treatments.

7. Esophageal varices.

8. Active esophagitis.

9. Esophageal stricture preventing passage of endoscope or catheter.

10. Any previous esophageal surgery, except fundoplication without complications.

11. Medically uncorrectable hypotension or hypertension.

12. Any condition that in the opinion of the investigator would create an unsafe clinical
situation that would not allow the patient to safely undergo an endoscopic procedure
(lack of medical clearance).

13. Pregnant or lactating women or women of childbearing potential who do not employ a
reliable method of contraception as judged by the Investigator, and/or are not willing
to use reliable contraception for the duration of study participation.

14. Patient has known severe psychiatric disorder, substance abuse, or other reason for
being unable to follow trial follow-up instructions.

15. Patient has a known significant concomitant illness with a life expectancy of <1 year.

16. Patient is known to be currently enrolled in another investigational trial that could
interfere with the endpoint analyses of this trial.