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Completed

NCT Number: NCT01118585

Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Graham Regional Medical Center, Safford, Arizona, United States

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About this study

Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.

Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years
  • GERD for > 1 year
  • History of daily PPIs use for > 6 months
  • Moderate to severe typical or atypical GERD symptoms off PPIs
  • Complete (responders) or partial (nonresponders) symptom control on PPIs
  • Deteriorated gastroesophageal junction (Hill grade II or III)
  • Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
  • Willingness to undergo pH/impedance testing, if required
  • Willingness to cooperate with the postoperative diet for 6 weeks
  • Availability for follow up visits at 6 months and 12 months
  • Willingly and cognitively signed informed consent

Exclusion criteria

  • BMI > 35
  • Incompletely reducible hiatal hernia with residual of > 5 mm
  • Esophagitis grade D
  • Barrett's Esophagus > 2 cm
  • Esophageal ulcer
  • Fixed esophageal stricture or narrowing
  • Portal hypertension and/or varices
  • 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
  • Coagulation disorder
  • History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Pregnancy or plans of pregnancy in the next 12 months
  • Enrollment in another device or drug study that may confound the results

Treatment and study plan

TIF Procedure

Procedure

The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.

Other names: TIF - Transoral Incisionless fundoplication

Primary outcomes

  1. Gastroesophageal Reflux Disease (GERD) symptom elimination

    Time frame: 6-month follow-up

    GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).

Secondary outcomes

  1. Elimination of Proton Pump Inhibitor (PPI) usage

    Time frame: at 12-, 24- and 36-month follow-up

    Elimination of Proton Pump Inhibitor (PPI) usage

  2. Esophageal acid exposure

    Time frame: at 6-, 12-, 24- and 36-month follow-up

    Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.

  3. Healing of reflux esophagitis

    Time frame: at 12, 24- and 36-month follow-up

    Healing of reflux esophagitis

  4. Safety outcomes

    Time frame: first 30 days

    Incidence of anticipated and unanticipated adverse events

  5. Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination

    Time frame: at 12-, 24- and 36-month follow-up

    GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.

Sponsors and collaborators

Lead sponsor

EndoGastric Solutions

Industry

Registry information

Official study title

Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study

Important dates

Study start
2010
Primary completion
2015
Study completion
2018
First posted
May 6, 2010
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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