The EndoGastric Solutions TEMPO Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01647958
First received: June 22, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Device: EsophyX System with SerosaFuse fasteners
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms

Resource links provided by NLM:


Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • GERD symptom elimination or clinically significant improvement evaluated by GERD-HRQL, RSI and RDQ. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPIs as evaluated by the disease specific and validated instruments: (1) GERD-Health-Related Quality of Life (HRQL) questionnaire (2) Reflux Symptom Index (RSI) and (3) Reflux Disease Questionnaire (RDQ).


Secondary Outcome Measures:
  • Elimination of daily bothersome GERD symptoms [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Elimination of daily bothersome GERD symptoms as measured by scores of ≤2 for each GERD-HRQL question or RSI questions.

  • PPI discontinuation [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    Elimination of daily bothersome GERD symptoms as measured by complete discontinuation of PPI therapy at 12-, 24- and 36-month follow-up.

  • Normalization of esophageal acid exposure [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    Elimination of moderate to severe regurgitation with intensity reduced to one day a week as measured by RDQ or clinically significant improvement defined as ≥ 50% reduction in total scores at 12-, 24-, and 36-month follow-up.

  • Healing or reduction of esophagitis. [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    Elimination of daily bothersome GERD symptoms as measured by healing or reduction of esophagitis.


Other Outcome Measures:
  • PPI discontinuation--crossover patients [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Elimination of daily bothersome GERD symptoms in crossover patients as measured by discontinuation of PPI therapy at 6-, 18- and 30-month follow-up.

  • Elimination of daily bothersome GERD symptoms in crossover patients [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Elimination of daily bothersome GERD symptoms in crossover patients as measured by scores of ≤2 for each GERD-HRQL question or RSI questions.


Enrollment: 65
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
Device: EsophyX System with SerosaFuse fasteners
Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication
No Intervention: Control
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.

Detailed 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-, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647958

Locations
United States, California
EndoGastric Solutions
Redwood City, California, United States, 94065
Sponsors and Collaborators
EndoGastric Solutions
Investigators
Principal Investigator: Karim Trad, MD, FACS Reston Surgical Associates
  More Information

Additional Information:
No publications provided

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01647958     History of Changes
Other Study ID Numbers: D01292
Study First Received: June 22, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by EndoGastric Solutions:
TEMPO
TIF
Transoral Incisionless Fundoplication
EsophyX System
refractory symptoms
proton pump inhibitors
EndoGastric Solutions
EGS
Acid Reflux
Heartburn
Regurgitation

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014