Purpose: To evaluate the safety and efficacy of the NDO Plicator endoscopic procedure for the treatment of symptomatic GERD in a cohort of patients followed out to 12 months from their original participation in a sham-controlled study.
Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled. Excluded from treatment were patients with esophageal dysmotility, esophagitis grade III or IV (Savary-Miller), Barrett's epithelium, and hiatus hernia >2 cm. All patients received a single, endoscopically placed full-thickness plication in the anterior gastric cardia. The primary study endpoint was ≥50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included VAS, SF-36, GERD medication use, and esophageal acid exposure.
Results: A total of 148 patients were treated at 14 study sites. No re-treatments were performed. Twelve-months post-plication, 59/96 patients (62%) had improved their GERD-HRQL score by at least 50%. Median percent change in GERD-HRQL score (62%), VAS score (46%), heartburn score (67%) and regurgitation score (50%) were all significantly improved compared to off meds baseline values. The need for daily PPI therapy was either eliminated or reduced by at least half in 63% of patients at 12-months post-treatment. There were no new or late onset adverse events.
Conclusion: At 12-months post-procedure, the cohort originally treated with full-thickness plication with the Plicator and the cross-over group treated after sham showed the endoscopic treatment to be safe and effective in reducing GERD symptoms and medication use.