Hernia Reduction Prior to Scheduled TIF Completion

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

• EsophyX ZR transoral device (Device): TIF

Primary outcomes

• pH Study [48 hour monitoring period]: Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in

Secondary outcomes

• Number of Participants With a Change in Troublesome Symptoms From Baseline [6 months]: Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week
• Number of Participants With a Change in PPI Consumption From Baseline to 6 Months [6 months]: from daily use to occasional use or none at all.

Sex: All, ages: 18 Years to 72 Years

Inclusion Criteria:

1. Age 18-72 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 required)
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 interest.

Post Enrollment Exclusion -

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

Participant flow

Outcome results

• pH Study (Primary), Count of participants, Participants: TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) 6
• Number of Participants With a Change in Troublesome Symptoms From Baseline (Secondary), Count of participants, Participants: TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) 3
• Number of Participants With a Change in PPI Consumption From Baseline to 6 Months (Secondary), Count of participants, Participants: TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) 8

Adverse events

Time frame: 6 months

Serious adverse events by term

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2017-12-19)

• Michael Murray, MD,FACS, Principal investigator, Northern Nevada Medical Group