The EndoGastric Solutions TEMPO Trial

The objective of this study is to assess the efficacy and safety of TIF performed with
EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD
patients with medically refractory GERD symptoms other than heartburn.

Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving
daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month
follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or
significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if
present, at 12-, 24-, and 36-month follow-up. The majority of surgical patients will have
normalized or 50% improved esophageal acid exposure compared to baseline at 6-month
follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24- and
36-month follow-up compared to baseline. The majority of crossover patients will be
completely off PPIs at 6-, 18-, and 30-month follow-up compared to baseline. A statistically
greater proportion of crossover patients treated with TIF will be free of daily bothersome
symptom(s) or will experience clinically significant improvement at 6-, 18-, and 30-month
follow-up.

Inclusion Criteria:

1. Age 18-80 years;

2. GERD for > 1 year;

3. History of daily PPIs for > 6 months;

4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn
on PPIs;

5. Hill grade I and II at gastroesophageal junction;

6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow
testing;

7. Willingness to undergo pH testing;

8. Willingness to cooperate with the postoperative diet;

9. Availability for follow-up visits at 6, 12, 24, and 36 months;

10. Willingly and cognitively signed inform consent

Exclusion Criteria:

1. BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse
dimension;

2. Esophagitis grade C and D;

3. Barrett's esophagus > 2 cm;

4. Esophageal ulcer;

5. Fixed esophageal stricture or narrowing;

6. Portal hypertension and/or varices;

7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;

8. Gastroparesis;

9. Coagulation disorders;

10. History of any of the following: resective gastric or esophageal surgery, antireflux
surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical
spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia,
scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;

11. Pregnancy or plans of pregnancy in the next 12 months;

12. Enrollment in another device or drug study that may confound the results