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The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.
Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).
Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.
Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham placebo procedure | Placebo Comparator | Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. |
|
| TIF Transoral Fundoplication | Active Comparator | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIF Transoral Fundoplication | Device | A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition, | Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group. | 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score | DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are:
The composite score can be obtained by adding the scores calculated for each of the six components. |
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Inclusion Criteria:
Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hunter, MD FACS | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| SurgOne PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25448925 | Derived | Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Placebo Procedure | Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham placebo procedure | Other | The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus. |
|
|
| 6 months post procedure |
| Englewood |
| Colorado |
| 80110 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Ohio State University Hospital | Columbus | Ohio | 43211 | United States |
| The Oregon Clinic | Portland | Oregon | 97210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Texas, Health Science Center at Houston | Houston | Texas | 77401 | United States |
| Reston Surgical Associates | Reston | Virginia | 20190 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| FG001 | TIF Transoral Fundoplication | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Placebo Procedure | Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus. |
| BG001 | TIF Transoral Fundoplication | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition, | Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group. | Patients completing 6 month post-procedure follow-up | Posted | Count of Participants | Participants | 6 month follow up |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score | DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are:
The composite score can be obtained by adding the scores calculated for each of the six components. | Patients that completed 6 month follow-up. NOTE: greater than 14.72 is considered abnormal, 14.72-50 is regarded as mild GERD, 51-100 is regarded as moderate GERD, and greater than 100 is regarded as severe GERD. | Posted | Mean | Full Range | Composite DeMeester Score | 6 months post procedure |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Placebo Procedure | Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. Sham placebo procedure: The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus. | 0 | 42 | 1 | 42 | 0 | 42 |
| EG001 | TIF Transoral Fundoplication | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) | 0 | 87 | 3 | 87 | 4 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Temporary epigastric /abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chest Pain | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary epigastric / abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Intent to treat (ITT) analysis included 12 patients with limited follow-up data. Assessment of the primary end point at 6 months can be viewed as premature by some; however, we believed it likely that delaying the primary end point beyond 6 months would risk patients not entering or dropping out of the study prematurely.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrain Lobontiu | EndoGastric Solutions | +16504749259 | alobontiu@endogastricsolutions.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006551 | Hernia, Hiatal |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005759 | Gastroenteritis |
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| Male |
|
| OG001 | TIF Transoral Fundoplication | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. TIF Transoral Fundoplication: A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) |
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