Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study - Full Text View

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:

MedlinePlus related topics: GERD Hernia Hiatal Hernia

U.S. FDA Resources

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.

Estimated Enrollment:	120
Study Start Date:	April 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	July 2013 (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

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, Colorado
SurgOne PC	Recruiting
Englewood, Colorado, United States, 80110
Contact: Rachel Hufford 303-788-8989 ext 211 rhufford@surgone.com
Principal Investigator: Reginald Bell, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Colleen Krantz ckrantz@nmh.org
Sub-Investigator: Peter Kahrilas, MD
Principal Investigator: Nathaniel Soper, MD
Sub-Investigator: Eric Hungness, MD
United States, Ohio
Ohio State University Hospital	Recruiting
Columbus, Ohio, United States, 43211
Contact: Rebecca Dettorre 614-293-8549 becky.detorre@osumc.edu
Principal Investigator: Kyle Perry, MD
Sub-Investigator: Scott Melvin, MD
United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Kathy Powell 503-494-4949 powellka@ohsu.edu
Principal Investigator: John Hunter, MD
Sub-Investigator: James Dolan, MD
The Oregon Clinic	Recruiting
Portland, Oregon, United States, 97210
Contact: Angi Gill 503-281-0561 agill@orclinic.com
Principal Investigator: Lee Swanstrom, MD
Sub-Investigator: Christy Dunst, MD
Sub-Investigator: Kevin Reavis, MD
United States, Texas
University of Texas, Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77401
Contact: Anna Tenorio 713-486-1350 Anna.Cecilia.S.Tenorio@uth.tmc.edu
Principal Investigator: Erik Wilson, MD
United States, Virginia
Reston Surgical Associates	Recruiting
Reston, Virginia, United States, 20190
Contact: Maureen Turgeon 703-796-0370 doctorturgeon@aol.com
Principal Investigator: Karim Trad, MD
Sub-Investigator: Daniel Turgeon, MD
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Linda Harrison 206-221-3341 lsh3@u.washington.edu
Contact: Mehakpreet Romana 206-897-1495 mkr9@u.washington.edu
Principal Investigator: Brant Oelschlager, MD

Sponsors and Collaborators

EndoGastric Solutions

More Information

No publications provided

Responsible Party:	Gheda Sahyun, Senior Director of Clinical Affairs, EndoGastric Solutions
ClinicalTrials.gov Identifier:	NCT01136980 History of Changes
Other Study ID Numbers:	D01010
Study First Received:	June 2, 2010
Last Updated:	November 29, 2012
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 May 19, 2013