The EndoGastric Solutions TEMPO Trial

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: EndoGastric Solutions

Criteria

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