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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: EndoGastric Solutions

Current Primary Outcome: 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).


Original Primary Outcome: GERD symptoms [ Time Frame: at 6 month follow-up ]

GERD symptom elimination or clinically significant reduction is defined as ≥ 50% improvement in the total QOLRAD, GSRS and RSI scores compared to baseline off PPIs.


Current Secondary Outcome:

  • Elimination of Proton Pump Inhibitor (PPI) usage [ Time Frame: at 12-, 24- and 36-month follow-up ]
  • 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.
  • Healing of reflux esophagitis [ Time Frame: at 12, 24- and 36-month follow-up ]
  • Safety outcomes [ Time Frame: first 30 days ]
    Incidence of anticipated and unanticipated adverse events
  • 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.


Original Secondary Outcome:

  • Elimination of PPI usage [ Time Frame: at 6 and 12 month follow-up ]
  • Esophageal acid exposure [ Time Frame: at 6 and 12 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.
  • Healing of reflux esophagitis [ Time Frame: at 6 and 12 month follow-up ]
  • Safety outcomes [ Time Frame: first 30 days ]
    Incidence of anticipated and unanticipated adverse events
  • GERD symptoms [ Time Frame: at 12 month follow-up ]
    GERD symptom elimination or clinically significant reduction is defined as ≥ 50% improvement in the total QOLRAD, GSRS and RSI scores compared to baseline off PPIs.


Information By: EndoGastric Solutions

Dates:
Date Received: April 30, 2010
Date Started: May 2010
Date Completion: December 2017
Last Updated: February 7, 2017
Last Verified: February 2017