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The EndoGastric Solutions TEMPO Trial (TEMPO)

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EsophyX System with SerosaFuse fasteners
PPI
Sponsored by
EndoGastric Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring TEMPO, TIF, Transoral Incisionless Fundoplication, EsophyX System, refractory symptoms, proton pump inhibitors, EndoGastric Solutions, EGS, Acid Reflux, Heartburn, Regurgitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • EndoGastric Solutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.
Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment
Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.

Secondary Outcome Measures

Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation
Elimination of daily bothersome GERD (Gastro Esophageal Reflux Disease) HRQL symptoms, using RDQ (Reflux Disease Questionnaire), RSI (Reflux Symptom Index) and as measured by complete discontinuation of PPI (Proton Pump Inhibitors) therapy at 6-month follow-up.
Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry
Assessment of esophageal acid exposure with normal defined as pH<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days
Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading
Esophagitis graded using the LA grading system through endoscopic visualization. Data entered represents study participants with complete healing or reduction in reflux esophagitis compared to baseline results. Note that Control arm patients were assessed while on PPIs. LA grades are A, B, C, D, with A being the least severe. Grade D was an exclusion criteria. Normal has no associated grade.

Full Information

First Posted
June 22, 2012
Last Updated
November 6, 2020
Sponsor
EndoGastric Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01647958
Brief Title
The EndoGastric Solutions TEMPO Trial
Acronym
TEMPO
Official Title
Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoGastric Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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-, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
TEMPO, TIF, Transoral Incisionless Fundoplication, EsophyX System, refractory symptoms, proton pump inhibitors, EndoGastric Solutions, EGS, Acid Reflux, Heartburn, Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
EsophyX System with SerosaFuse fasteners
Intervention Description
Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners
Intervention Type
Drug
Intervention Name(s)
PPI
Other Intervention Name(s)
same brand of PPI used by all Control Arm participants
Intervention Description
Control Arm participants will take maximum standard dose of PPI during Initial Study period
Primary Outcome Measure Information:
Title
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).
Description
Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.
Time Frame
6 months
Title
Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment
Description
Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation
Description
Elimination of daily bothersome GERD (Gastro Esophageal Reflux Disease) HRQL symptoms, using RDQ (Reflux Disease Questionnaire), RSI (Reflux Symptom Index) and as measured by complete discontinuation of PPI (Proton Pump Inhibitors) therapy at 6-month follow-up.
Time Frame
6 Months
Title
Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry
Description
Assessment of esophageal acid exposure with normal defined as pH<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days
Time Frame
6 Months
Title
Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading
Description
Esophagitis graded using the LA grading system through endoscopic visualization. Data entered represents study participants with complete healing or reduction in reflux esophagitis compared to baseline results. Note that Control arm patients were assessed while on PPIs. LA grades are A, B, C, D, with A being the least severe. Grade D was an exclusion criteria. Normal has no associated grade.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire
Description
Elimination of daily bothersome heartburn as measured by GERD-HRQL (Gastro Esophageal Reflux Disease - Health-Related Quality of Life) questionnaire. GERD-HRQL is a validated questionnaire used to assess typical GERD symptoms by measuring 10 items on the visual analog scale ranging from 0 (no symptoms) to 5 (worst symptoms). A higher total GERD-HRQL score (range from 0 to 50) indicates more severe GERD. Note Control Arm patients are assessed while on standard daily dose of PPIs.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Trad, MD, FACS
Organizational Affiliation
Reston Surgical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
EndoGastric Solutions
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25284142
Citation
Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA, Mavrelis PG. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol. 2014 Oct 6;14:174. doi: 10.1186/1471-230X-14-174.
Results Reference
derived
Links:
URL
http://www.endogastricsolutions.com
Description
EndoGastric Solutions Company Page

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The EndoGastric Solutions TEMPO Trial

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