TECR & ECM Placement for Esophageal High Grade Dysplasia

This is a single-center, prospective, single arm study involving 10 patients with an
established diagnosis of Barrett's Esophagus (BE) with High Grade Dysplasia (HGD). Potential
subjects will be prescreened to assess eligibility and must meet inclusion criteria. In order
to make this initial qualification, pathology results of biopsies and EMR collected during
initial EGD will be made available to the Investigator prior to patient consent. Following
informed consent and as part of routine care, all potential participants will undergo
endoscopic ultrasound (EUS) and a PET/CT scan to confirm that there is no lymph node
involvement or other metastatic lesions prior to the procedure. Clinical data will be
collected at baseline to assess the subjects' medical status including: demographics, medical
history, physical examination, vital signs, and blood testing. Cardiac and pulmonary
clearance will be obtained if needed based on medical history and will include a chest x-ray,
ECG, and pulmonary function test. In addition, the subjects will complete three
questionnaires prior to the procedure: dysphagia severity questionnaire, SF-36, and
GERD-HRQL.

At the time of the procedure, participants will undergo TECR with ECM placement using a fully
covered self-expanding metal stent to temporarily hold the ECM in place. Prior to hospital
discharge, a barium swallow test (BaSW) will be performed at Day 1 following the study
procedure to evaluate the passage of contrast through the GEJ. If the BaSW results in
suspicious findings of esophageal perforation or mucosal necrosis, an upper endoscopy will be
performed for further evaluation. The first primary safety endpoint for this study will be
assessed following the procedure and BaSW and before discharge from the hospital. At this
time point any adverse events will be assessed and recorded.

All subjects will undergo the same follow-up procedures, including questionnaires and
post-procedure EGDs performed at Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 to
visually assess tissue healing, recurrent disease, and if stricture formation is present.
Biopsies will be taken during follow-up EGDs so that pathology can rule out recurrence of BE
and HGD. Subjects will have a barium swallow x-ray at Month 1, Month 3, Month 6, Month 9, and
Month 12 to evaluate the potential presence of stricture formation.

During Week 2 EGD, the stent will be removed during the upper endoscopy. If at any time point
a subject has dysphagia with stricture formation (30% reduction in esophageal luminal
diameter), routine dilation using a balloon catheter will be performed during the EGD.
Validated questionnaires including dysphagia severity questionnaire, SF-36 and GERD-HRQL will
be administered to objectively assess the severity of symptoms and quality of life based upon
self-reported data. Additionally, adverse events will be assessed and recorded at all
follow-up time points.

After completion of the Month 12 visit, subjects will be followed on a routine care basis at
the Esophageal & Lung Institute.

Inclusion Criteria:

1. Be at least 18 years of age and no more than 80 years of age.

2. Have an established diagnosis of HGD

a. Specific diagnosis and grading will be determined by pathology review of biopsy
tissue collected during baseline EGD as part of a patient's standard of care.

3. Have no evidence of lymphovascular invasion.

4. Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.

5. Diameter of affected tissue must warrant circumferential excision a. Subjects must
have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced
two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are
normal (contain no HGD) they must be located on separate levels in two different
quadrants.

5. Must be an appropriate or reasonable surgical candidate. 6. Have demonstrated an
understanding and signed an approved informed consent form for participation in this study.

Exclusion Criteria:

1. Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal
adenocarcinoma).

a. Those requiring endoscopic submucosal dissection (ESD) are not eligible for this
study

2. Have presence of lymphovascular invasion.

3. Require resection length longer than 10 cm.

4. Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.

5. Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).

6. Are pregnant or planning to become pregnant.

7. Have coagulation disorders.

8. Have a known hypersensitivity to porcine-based materials.

9. Have an uncontrolled comorbid medical condition that would adversely affect
participation in the trial.

10. Has a clinically significant psychological illness that in the physician's opinion
would prohibit the subject's ability to meet the protocol requirements.

11. Are unable or unwilling to provide informed consent and/or fulfill the protocol
follow-up requirements.