Clinical trial NCT02505945: The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Official title: The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD Gastroesophageal Reflux Disease
Keywords: Esophageal Reflux
Gastric Acid Reflux Disease
Heartburn
Lead sponsor: Torax Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 152
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Prospective, multicenter, 2:1 randomized, cross-over, two arms

* Control arm: Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\]
* Treatment arm: LINX Reflux Management System Up to 20 study centers throughout the U.S. will participate. Approximately150 patients will be enrolled into the study. Subjects will be randomized 2:1 into the double-dose PPIs arm (100 subjects) and the LINX arm (50 subjects).

Eligibility criteria: 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.

Primary outcomes:
measure: Elimination of Moderate-severe Regurgitation at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Heber Springs
country: United States
facility: Bapist Health
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: Englewood
country: United States
facility: SurgOne Foregut Institute
state: Colorado
city: Albany
country: United States
facility: Albany Surgical PC
state: Georgia
city: Atlanta
country: United States
facility: Esophageal Institute of Atlanta, PC.
state: Georgia
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Crosby
country: United States
facility: Cuyuna Regional Medical Center
state: Minnesota
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Saranac Lake
country: United States
facility: Adirondack Surgical Group, LLC
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Geauga
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Round Rock
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: La Crosse
country: United States
facility: Gundersen Lutheran
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Rogers BD, Valdovinos LR, Crowell MD, Bell R, Vela MF, Gyawali CP. Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation. Gut. 2021 Mar;70(3):450-455. doi: 10.1136/gutjnl-2020-321395. Epub 2020 May 28.
citation: Bell R, Lipham J, Louie BE, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1736-1743.e2. doi: 10.1016/j.cgh.2019.08.056. Epub 2019 Sep 10.
citation: Bell R, Lipham J, Louie B, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. 2019 Jan;89(1):14-22.e1. doi: 10.1016/j.gie.2018.07.007. Epub 2018 Jul 18.