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The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.
Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIF Procedure | Other | Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIF Procedure | Procedure | The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) symptom elimination | GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index). | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of Proton Pump Inhibitor (PPI) usage | Elimination of Proton Pump Inhibitor (PPI) usage | at 12-, 24- and 36-month follow-up |
| Esophageal acid exposure | Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reginald CW Bell, MD, FACS | SurgOne P.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Graham Regional Medical Center | Safford | Arizona | 85546 | United States | ||
| Tempe St. Luke's Hospital |
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| Label | URL |
|---|---|
| Click here for more information about this study: TIF Registry study | View source |
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|
| at 6-, 12-, 24- and 36-month follow-up |
| Healing of reflux esophagitis | Healing of reflux esophagitis | at 12, 24- and 36-month follow-up |
| Safety outcomes | Incidence of anticipated and unanticipated adverse events | first 30 days |
| Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination | GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores. | at 12-, 24- and 36-month follow-up |
| Tempe |
| Arizona |
| 85281 |
| United States |
| Swedish Medical Center and SurgOne P.C. | Englewood | Colorado | 80110 | United States |
| Munroe Regional Hospital | Ocala | Florida | 34471 | United States |
| St Mary's Hospital | Hobart | Indiana | 46342 | United States |
| Livingston Hospital and Healthcare Services, Inc. CAH | Salem | Kentucky | 42078 | United States |
| The Surgeons Group of Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| Allegan Surgical Associates | Allegan | Michigan | 49010 | United States |
| Crossville Medical Group | Crossville | Tennessee | 38555 | United States |
| Ihde Surgical Group, PA | Arlington | Texas | 76014 | United States |
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| Master Center for Minimally Invasive Surgery | Southlake | Texas | 76092 | United States |
| Utah County Surgical Associates | Provo | Utah | 84604 | United States |
| Reston Hospital | Reston | Virginia | 20190 | United States |
| 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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