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

Endogastric Solutions

Status: Completed

Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease

Treatments: Other: Sham placebo procedure; Device: TIF Transoral Fundoplication

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136980

D01010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 2 patient groups, including a placebo group

Sham placebo procedure

Placebo Comparator group

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.

Treatment:

Other: Sham placebo procedure

TIF Transoral Fundoplication

Active Comparator group

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.

Treatment:

Device: TIF Transoral Fundoplication