Back to resultsRetrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study (RetroTIF)
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transoral Incisionless Fundoplication
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal reflux disease, GERD, Heartburn, Reflux, Regurgitation, Hoarseness, Cough
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
Sites / Locations
- Munroe Regional Medical Center
- Livingston Hospital and Healthcare Services, Inc. CAH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transoral Incisionless Fundoplication
Arm Description
Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0). With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GastroEsophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01327963
Brief Title
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
Acronym
RetroTIF
Official Title
Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The sponsor is focusing on prospective randomized studies
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoGastric Solutions
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal reflux disease, GERD, Heartburn, Reflux, Regurgitation, Hoarseness, Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transoral Incisionless Fundoplication
Arm Type
Experimental
Arm Description
Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0).
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GastroEsophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Intervention Type
Device
Intervention Name(s)
Transoral Incisionless Fundoplication
Other Intervention Name(s)
TIF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Description
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.
Time Frame
median 7 months (range 5-17 months)
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
Description
The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
Time Frame
median 7 months (range 5-17 months)
Title
Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
Description
Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
Time Frame
median 7 months (range 5-17 months)
Title
Number of Participants With Healing of Reflux Esophagitis
Description
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.
Time Frame
median 7 months (range 5-17 months)
Title
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
Description
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.
Time Frame
median 7 months (range 5-17 months)
Title
Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes
Description
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.
Time Frame
median 7 months (range 5-17 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Barnes, MD MBA FACS
Organizational Affiliation
Livingston Hospital and Healthcare Services Inc, CAH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Livingston Hospital and Healthcare Services, Inc. CAH
City
Salem
State/Province
Kentucky
ZIP/Postal Code
42078
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
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