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

NCT01025739 | Withdrawn Phase 2 DMC

• 1 other identifier: Pro00004475
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Gastroesophageal Reflux Disease (GERD); EsophyX

Outcome Measures

Primary Outcomes (1)

• 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores

  1, 3, 6, 12 month

Secondary Outcomes (1)

• 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.

  1 day; 1 week; 1, 3, 6, 12 month

Interventions

EsophyX™ system with SerosaFuse fasteners DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Erosive esophagitis (erosions or ulcerations during endoscopy)
• Abnormal ambulatory pH study
• 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

You may not qualify if:

• BMI \> 40
• Hiatal hernia \> 2 cm
• Esophagitis grade D
• Esophageal ulcer
• Esophageal stricture
• Esophageal motility disorder
• Prior splenectomy
• 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
• Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment

Sponsors & Collaborators

• University of Alberta: lead
• AHS Cancer Control Alberta: collaborator

Study Sites (1)

CAMIS, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (24)

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MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, MD, FRCSC, FACS

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

CA (1)