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Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (RESPECT)

Primary Purpose

Gastroesophageal Reflux Disease, Hiatal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIF Transoral Fundoplication
Sham placebo procedure
Sponsored by
EndoGastric Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years
  • Dependent upon daily PPIs for > 6 months
  • Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.

  • Abnormal ambulatory pH study off PPI therapy for 7 days.
  • Normal or near normal esophageal motility (by manometry)
  • Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Exclusion Criteria:

  • BMI > 35
  • Hiatal hernia > 2 cm
  • Esophagitis Los Angeles grade C or D
  • Esophageal ulcer
  • Esophageal stricture
  • Esophageal motility disorder
  • Pregnancy or plans for pregnancy in the next 12 months (in females)
  • Immunosuppression
  • ASA > 2
  • Portal hypertension and/or varices
  • History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
  • Coagulation disorders
  • Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.

Sites / Locations

  • Cedars Sinai Medical Center
  • SurgOne PC
  • Northwestern University
  • Ohio State University Hospital
  • The Oregon Clinic
  • Oregon Health and Science University
  • University of Texas, Health Science Center at Houston
  • Reston Surgical Associates
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham placebo procedure

TIF Transoral Fundoplication

Arm Description

Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.

Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.

Outcomes

Primary Outcome Measures

Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,
Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.

Secondary Outcome Measures

Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are: total number of episodes of reflux, - reflux is undesirable, therefore lower numbers are better, higher numbers are worse. Ideally there would be zero reflux episodes. % total time esophageal pH < 4, upright position and supine position, respectively - pH < 4 is undesirable, therefor lower percentages are better number of episodes longer than 5 minutes, - lower is better maximal reflux duration, (reflux is undesirable - lower is better total percentage of time with pH below 4 - below 4 is undesirable - lower is better The composite score can be obtained by adding the scores calculated for each of the six components.

Full Information

First Posted
June 2, 2010
Last Updated
December 1, 2021
Sponsor
EndoGastric Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01136980
Brief Title
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Acronym
RESPECT
Official Title
A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
March 2018 (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 objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.
Detailed Description
Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ). Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity. Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Hiatal Hernia
Keywords
GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham placebo procedure
Arm Type
Placebo Comparator
Arm Description
Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.
Arm Title
TIF Transoral Fundoplication
Arm Type
Active Comparator
Arm Description
Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.
Intervention Type
Device
Intervention Name(s)
TIF Transoral Fundoplication
Other Intervention Name(s)
TIF
Intervention Description
A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)
Intervention Type
Other
Intervention Name(s)
Sham placebo procedure
Other Intervention Name(s)
Sham Procedure
Intervention Description
The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
Primary Outcome Measure Information:
Title
Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,
Description
Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
Description
DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are: total number of episodes of reflux, - reflux is undesirable, therefore lower numbers are better, higher numbers are worse. Ideally there would be zero reflux episodes. % total time esophageal pH < 4, upright position and supine position, respectively - pH < 4 is undesirable, therefor lower percentages are better number of episodes longer than 5 minutes, - lower is better maximal reflux duration, (reflux is undesirable - lower is better total percentage of time with pH below 4 - below 4 is undesirable - lower is better The composite score can be obtained by adding the scores calculated for each of the six components.
Time Frame
6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Dependent upon daily PPIs for > 6 months Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent. Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity. Abnormal ambulatory pH study off PPI therapy for 7 days. Normal or near normal esophageal motility (by manometry) Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm Patient willing to cooperate with post-operative dietary recommendations and assessment tests Signed informed consent Exclusion Criteria: BMI > 35 Hiatal hernia > 2 cm Esophagitis Los Angeles grade C or D Esophageal ulcer Esophageal stricture Esophageal motility disorder Pregnancy or plans for pregnancy in the next 12 months (in females) Immunosuppression ASA > 2 Portal hypertension and/or varices History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis Active gastro-duodenal ulcer disease Gastric outlet obstruction or stenosis Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment Coagulation disorders Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hunter, MD FACS
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
SurgOne PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43211
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas, Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Reston Surgical Associates
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25448925
Citation
Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.
Results Reference
derived

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Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

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