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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01136980
First received: June 2, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Hiatal Hernia
Device: Transoral Incisionless Fundoplication
Other: Sham Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • A clinically significant reduction in GERD symptoms (specifically "Troublesome" regurgitation with or without heartburn as assessed by the RDQ per the Montreal Consensus definition. [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

    Primary efficacy hypothesis 1: At 6-month follow-up, the proportion of TIF2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI treatment group.

    Secondary efficacy hypothesis 1: At 6-month follow-up, with all patients off PPIs, the proportion of TIF patients with normalized esophageal acid exposure will be statistically significantly higher than the sham group.



Secondary Outcome Measures:
  • The normalization of esophageal acid exposure and healing of reflux esophagitis [ Time Frame: at 6 months and PPI usage at 12 months. ] [ Designated as safety issue: Yes ]
    At 12-month follow-up, ≥ 50% of the patients randomized to TIF will have a clinically significant reduction in PPI consumption as compared with their pre-TIF consumption. Clinical significant reduction is defined as from daily use to occasional use or none at all.


Enrollment: 129
Study Start Date: April 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham Procedure
Sham procedure consisting of upper GI endoscopy
Other: Sham Procedure
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.
Other Names:
  • Sham
  • Placebo
Experimental: TIF Procedure
TIF Procedure using EsophyX
Device: Transoral Incisionless Fundoplication
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)
Other Names:
  • EsophyX Device
  • EsophyX TIF
  • Transoral Incisionless Fundoplication
  • TIF

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136980

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
SurgOne PC
Englewood, Colorado, United States, 80110
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Ohio
Ohio State University Hospital
Columbus, Ohio, United States, 43211
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
The Oregon Clinic
Portland, Oregon, United States, 97210
United States, Texas
University of Texas, Health Science Center at Houston
Houston, Texas, United States, 77401
United States, Virginia
Reston Surgical Associates
Reston, Virginia, United States, 20190
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
EndoGastric Solutions
  More Information

No publications provided

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01136980     History of Changes
Other Study ID Numbers: D01010
Study First Received: June 2, 2010
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by EndoGastric Solutions:
GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on April 17, 2014