Lead Sponsor

NDO Surgical, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.
•GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
•Pathologic esophageal acid exposure, defined as pH\<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score \> 14.7
•Lower esophageal resting pressure of at least 5mmHg; and
•Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).

•Significant esophageal dysmotility as determined by manometry
•Esophagitis grade III or IV (Savary-Miller)
•Barrett's epithelium
•Hiatus hernia \> 2cm
•Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
•Esophageal or gastric varices
•Previous endoscopic or surgical anti-reflux procedure
•Other esophageal or gastric surgery
•Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
•Pregnancy.

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