CompletedNot Applicable

The EndoGastric Solutions TEMPO Trial

United States65 participantsStarted 2012-06-01

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

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;

What they're measuring

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).

Timeframe: 6 months

Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment

Timeframe: 6 months

Trial details

NCT IDNCT01647958

SponsorEndoGastric Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-01

Results submitted2019-03-04

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease (GERD) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

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;

What they're measuring

Timeframe: 6 months

Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment

Timeframe: 6 months