Hernia Reduction Prior to Scheduled TIF Completion

Age Range:18 - 65
Start Date:October 5, 2018
End Date:August 30, 2019
Contact:Cynthia C Harris, B.S.

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Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study

Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device

Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral
device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal
Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the
Montreal consensus definition

Inclusion Criteria:

1. Age 18-65 years

2. Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or
full dose or half dose taken daily for more than 80% of the total number of days
during the proceeding evaluation period

3. Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose
of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a
minimum of 2 days a week and are mild to severe in severity

4. Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of
the time with pH < 4 in a 48-hour monitoring period

5. Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as

6. Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to
4 cm inclusive.

7. Patient willing to cooperate with post-operative dietary recommendations and
assessment tests at the requisite follow-up visits

8. Signed informed consent Exclusion Criteria

1. BMI > 35 2. Hiatal hernia ≤ 2 and > 4 cm 3. Esophagitis Los Angeles grade C or D 4.
Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C > 1,
M > 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12
months (in females) 9. Immunosuppression 10. ASA > 2 11. Portal hypertension and/or varices
12. History of previous resective gastric or esophageal surgery, cervical spine fusion,
Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or
dermatomyositis, eosinophilic esophagitis, or cirrhosis 13. Active gastro-duodenal ulcer
disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed
gastric emptying confirmed by solid-phase gastric emptying study if patient complains of
postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms
including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion
of the investigator would not make participation in this study in the patient's best

Post Enrollment Exclusion -

1. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.
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