N/A
Completed N=65
The EndoGastric Solutions TEMPO Trial
Gastroesophageal Reflux Disease (GERD)
Source: ClinicalTrials.gov NCT01647958 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire). — 24; 1 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire). |
24; 1 | — |
| PRIMARY Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment |
29; 9 | — |
| SECONDARY Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation |
35; 0 | — |
| SECONDARY Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry |
21; 11 | — |
| SECONDARY Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading |
18; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-80 years;
- GERD for > 1 year;
- History of daily PPIs for > 6 months;
- At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
- Hill grade I and II at gastroesophageal junction;
- Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
- Willingness to undergo pH testing;
- Willingness to cooperate with the postoperative diet;
- Availability for follow-up visits at 6, 12, 24, and 36 months;
- Willingly and cognitively signed inform consent
Exclusion Criteria
- BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse dimension;
- Esophagitis grade C and D;
- Barrett's esophagus > 2 cm;
- Esophageal ulcer;
- Fixed esophageal stricture or narrowing;
- Portal hypertension and/or varices;
- Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
- Gastroparesis;
- Coagulation disorders;
- 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;
- Pregnancy or plans of pregnancy in the next 12 months;
- Enrollment in another device or drug study that may confound the results
Data sourced from ClinicalTrials.gov (NCT01647958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.