Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

Gastroesophageal Reflux Disease (GERD) Clinical Trial

— RetroTIF  

Official title:

Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01327963
• Other study ID #: D01079
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2020
• Source: EndoGastric Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Device:
• Transoral Incisionless Fundoplication
Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Locations

Country	Name	City	State
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Livingston Hospital and Healthcare Services, Inc. CAH	Salem	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination	Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of <18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of < or = 13) questionnaires) at the follow-up.	median 7 months (range 5-17 months)
Secondary	Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)	The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.	median 7 months (range 5-17 months)
Secondary	Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use	Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.	median 7 months (range 5-17 months)
Secondary	Number of Participants With Healing of Reflux Esophagitis	One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.	median 7 months (range 5-17 months)
Secondary	Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up	Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.	median 7 months (range 5-17 months)
Secondary	Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes	Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for = 6% of 24-hour or for = 5.3% of 48-hour monitoring period. The number of reflux episodes of = 44 per each 24-hour period will be considered normal.	median 7 months (range 5-17 months)