Clinical trial NCT01327963: Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
Official title: Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal reflux disease
GERD
Heartburn
Reflux
Regurgitation
Hoarseness
Cough
Lead sponsor: EndoGastric Solutions
Sponsor class: INDUSTRY
First posted: 2011-04-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

Detailed description: This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

Eligibility criteria: Inclusion Criteria:

* Age 18-85 years
* Have undergone the TIF procedure within the past 2 years
* History of daily proton pump inhibitor (PPI) use for \>6 months
* Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
* Deteriorated gastroesophageal junction (Hill grade II or III)
* Availability for a follow-up visit at 6,12 or 24 months
* Willingly and cognitively signed informed consent

Exclusion Criteria:

* Procedure not completed or performed following a non-standardized TIF protocol
* Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
* Pregnancy
* Enrollment in another device or drug study that may confound the results

Primary outcomes:
measure: Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
timeFrame: median 7 months (range 5-17 months)
Secondary outcomes:
measure: Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
timeFrame: median 7 months (range 5-17 months)
measure: Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
timeFrame: median 7 months (range 5-17 months)
measure: Number of Participants With Healing of Reflux Esophagitis
timeFrame: median 7 months (range 5-17 months)
measure: Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
timeFrame: median 7 months (range 5-17 months)
measure: Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes
timeFrame: median 7 months (range 5-17 months)
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Salem
country: United States
facility: Livingston Hospital and Healthcare Services, Inc. CAH
state: Kentucky
Study officials:
affiliation: Livingston Hospital and Healthcare Services Inc, CAH
name: William Barnes, MD MBA FACS
role: PRINCIPAL_INVESTIGATOR
References: