Gastroesophageal Reflux Disease (GERD) Clinical Trial
— RetroTIFOfficial title:
Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
NCT number | NCT01327963 |
Other study ID # | D01079 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | February 2014 |
Verified date | November 2020 |
Source | EndoGastric Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Munroe Regional Medical Center | Ocala | Florida |
United States | Livingston Hospital and Healthcare Services, Inc. CAH | Salem | Kentucky |
Lead Sponsor | Collaborator |
---|---|
EndoGastric Solutions |
United States,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03561883 -
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
|
Phase 3 | |
Completed |
NCT02555852 -
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
|
N/A | |
Completed |
NCT01406210 -
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
|
N/A | |
Completed |
NCT01570842 -
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
|
N/A | |
Completed |
NCT02141711 -
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses
|
Phase 1 | |
Terminated |
NCT00587275 -
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|
Phase 2 | |
Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
Completed |
NCT00261300 -
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
|
Phase 3 | |
Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
Completed |
NCT00795093 -
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
|
N/A | |
Completed |
NCT00394472 -
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
|
Phase 2 | |
Completed |
NCT00574925 -
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|
Phase 4 | |
Terminated |
NCT02749071 -
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
|
N/A | |
Recruiting |
NCT01129713 -
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
|
Phase 1/Phase 2 | |
Completed |
NCT00734747 -
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
Completed |
NCT00312806 -
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
|
Phase 3 | |
Not yet recruiting |
NCT05579587 -
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
|
||
Recruiting |
NCT02366169 -
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
|
N/A | |
Completed |
NCT01374074 -
Racial Disparity in Barrett's Esophagus
|
N/A | |
Terminated |
NCT00857597 -
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
|
Phase 3 |