Overview

This trial is active, not recruiting.

Conditions gastroesophageal reflux disease, hiatal hernia
Treatments transoral incisionless fundoplication (tif), sham procedure
Phase phase 3
Sponsor EndoGastric Solutions
Start date April 2011
End date April 2015
Trial size 129 participants
Trial identifier NCT01136980, D01010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Sham Comparator)
Upper GI endoscopy
sham procedure Sham
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.
(Experimental)
TIF using the EsophyX
transoral incisionless fundoplication (tif)
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)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
The normalization of esophageal acid exposure and healing of reflux esophagitis
time frame: at 6 months and PPI usage at 12 months.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by EndoGastric Solutions.