The CALIBER Trial is a multi-center randomized controlled trial comparing LINX to acid suppression medication (omeprazole) in patients with troublesome regurgitation. All patients had a diagnosis of GERD as confirmed by abnormal acid exposure time and moderate to severe regurgitation despite taking once-daily omeprazole. Patients were randomized to treatment with twice a day omeprazole or LINX. The primary endpoint of the trial was elimination of moderate to severe regurgitation at 6 months after treatment. Preliminary results reported at DDW showed*:
- 92.6% of patients treated with LINX achieved the primary endpoint success criteria versus 8.6% of patients treated with twice a day omeprazole.
- Significant improvement in quality of life was achieved in 88.9% of patients treated with LINX versus 6.8% of patients treated with twice a day omeprazole.
- Normal levels of reflux were restored in 92% of patients treated with LINX compared to 36% of patients treated with twice a day omeprazole.
*This data was presented at Digestive Disease Week 2017 (DDW) in Chicago, IL, by Dr. Reginald Bell, SurgOne Foregut Institute, Englewood, CO