The EndoGastric Solutions TEMPO Trial

Endogastric Solutions

Status: Completed

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: PPI; Device: EsophyX System with SerosaFuse fasteners

Study type: Interventional

Funder types: Industry

Identifiers

NCT01647958

D01292

Details and patient eligibility

About

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).

Full description

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-, 36-, 48- and 60-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-, 36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will be completely off PPIs at 6-, 18-, 30-, 42- and 54-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-, 30-, 42- and 54-month follow-up.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.

Treatment:

Device: EsophyX System with SerosaFuse fasteners

Control

Active Comparator group

Description:

Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial. Patients will be offered TIF crossover procedure upon completion of month-6 follow-up visit.

Treatment:

Drug: PPI