The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:1/9/2019
Start Date:June 2015
End Date:August 2018

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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).

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).

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.
We found this trial at
21
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: James Luketich, MD
Phone: 414-647-8583
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: John Lipham, MD
Phone: 323-442-6252
University of Southern California The University of Southern California is one of the world’s leading...
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Korman Research Pavilion%2c Suite 100
Philadelphia, Pennsylvania 19141
215-456-7215
Principal Investigator: Philip Katz, MD
Phone: 215-456-6141
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San Diego, California 92103
Principal Investigator: Garth Jacobsen, M.D.
Phone: 619-543-2379
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Albany, Georgia
Principal Investigator: Christopher Smith, MD
Phone: 229-434-4200
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Annapolis, Maryland 21401
Principal Investigator: Adrian Park, MD
Phone: 443-481-4943
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Atlanta, Georgia 30309
Principal Investigator: C. Daniel Smith, MD
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Cleveland, Ohio
Principal Investigator: Leena Khaitan, MD
Phone: 216-844-3602
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Crosby, Minnesota 56441
Principal Investigator: Howard McCollister, MD
Phone: 218-546-4323
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Edgewood, Kentucky 41017
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Englewood, Colorado 80110
Principal Investigator: Reginald C.W. Bell, MD
Phone: 303-788-7700
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Heber Springs, Arkansas 72543
Principal Investigator: Dan Lister, MD
Phone: 501-250-2020
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1900 South Ave
La Crosse, Wisconsin 54601
(608) 782-7300
Principal Investigator: Shanu Kothari, MD
Phone: 608-775-1103
Gundersen Lutheran Gundersen Health System is where caring meets excellence through a comprehensive health network...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Jon Gould, MD
Phone: 414-805-5928
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
Principal Investigator: William Richards, MD
Phone: 251-471-7988
University of South Alabama "University of South Alabama is a public institution that was founded...
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
(740) 393-9000
Principal Investigator: Lauren McDowell-Jacobs, MD
Phone: 740-393-9735
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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Neptune, New Jersey 07754
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Portland, Oregon 97210
Principal Investigator: Christy Dunst, MD
Phone: 503-281-0561
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Round Rock, Texas 78665
Principal Investigator: F Paul Buckley III, MD
Phone: 512-218-6375
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Saranac Lake, New York
Principal Investigator: Michael Hill, MD
Phone: 518-891-1610
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Seattle, Washington 98104
Principal Investigator: Brian Louie, MD
Phone: 206-386-2450
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