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Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

NCT01025739 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-29

No results posted yet for this study

Summary

Objectives of the Study:

The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.

The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.

Type of Study:

Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20

Inclusion Criteria:

Age 18-70 years, on daily PPIs for \> 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent

Exclusion Criteria:

BMI \> 40, hiatal hernia \> 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), 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, gastroparesis or delayed gastric emptying, coagulation disorders

Interventions:

Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)

Evaluation Criteria:

Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.

Safety: Adverse events will be mapped to standard terms and reported.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

EsophyX™ system with SerosaFuse fasteners

The EsophyX™ system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct the gastroesophageal junction through anterior partial fundoplication with tailored delivery of multiple fasteners during a single-device insertion.

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    collaborator OTHER

  • University of Alberta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01025739 on ClinicalTrials.gov