GERD Gastroesophageal Reflux Disease Clinical Trial
— CALIBEROfficial title:
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
| NCT number | NCT02505945 |
| Other study ID # | 4959 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | August 2018 |
| Verified date | December 2018 |
| Source | Torax Medical Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).
| Status | Completed |
| Enrollment | 152 |
| Est. completion date | August 2018 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Key Inclusion Criteria: 1. Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs. 2. Age= 21 years old. 3. Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment. 4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery). 5. Patient has provided written informed consent for participation in the randomized study. Key Exclusion Criteria: 1. Currently taking double-dose PPIs (twice daily dosing). 2. Hiatal hernia >3cm as determined by endoscopy. 3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences. 4. Esophagitis Grade C or D (Los Angeles classification). 5. Body mass index >35. 6. Diagnosed with an esophageal motility disorder LES. 7. Esophageal stricture or gross esophageal anatomic abnormalities 8. History of/or known Barrett's esophagus. 9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Surgical PC | Albany | Georgia |
| United States | Anne Arundel Medical Center | Annapolis | Maryland |
| United States | Esophageal Institute of Atlanta, PC. | Atlanta | Georgia |
| United States | University Hospitals Cleveland Medical Center - Geauga | Cleveland | Ohio |
| United States | Cuyuna Regional Medical Center | Crosby | Minnesota |
| United States | St. Elizabeth Healthcare | Edgewood | Kentucky |
| United States | SurgOne Foregut Institute | Englewood | Colorado |
| United States | Bapist Health | Heber Springs | Arkansas |
| United States | Gundersen Lutheran | La Crosse | Wisconsin |
| United States | University of Southern California | Los Angeles | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of South Alabama | Mobile | Alabama |
| United States | Knox Community Hospital | Mount Vernon | Ohio |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Albert Einstein Healthcare Network | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | The Oregon Clinic | Portland | Oregon |
| United States | Scott and White Memorial Hospital | Round Rock | Texas |
| United States | UCSD | San Diego | California |
| United States | Adirondack Surgical Group, LLC | Saranac Lake | New York |
| United States | Swedish Cancer Institute | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Torax Medical Incorporated |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Elimination of Moderate-severe Regurgitation at 6 Months | The primary endpoint was the percent of patients in both treatment arms who achieved elimination of moderate-severe regurgitation at 6 months, as reported on the foregut symptom questionnaire. | 6 months | |
| Secondary | Percentage of Subjects With =50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores | Successful Reduction at 6 months (=50% reduction in total) Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores from Baseline PPI On medication GERD HRQL scores. | 6 months |