Table 1.

Assessments performed and data collected

Visit	Assessments/data collected
Screening/baseline	• Informed consent and inclusion/exclusion criteria assessed • Demographics (date of birth, gender, race) • Height and weight • GERD history: duration of PPI use, years with GERD, GERD new onset or pre-existing after LSG • GERD-HRQL (on/off PPIs) and Foregut Symptoms Questionnaire (off PPIs) • Baseline GERD-related medication use • Esophageal pH measurements (off PPIs) • Endoscopy • Manometry/motility • Barium esophagram • Motivation for surgery
Implant/discharge	• Surgery date • Surgery start and stop time • Implanted device size • Concomitant procedures (e.g., hiatal hernia repair, cholecystectomy) • Barium esophagram and upright Bi-Planar X-Rays (AP and Lateral) • Discharge date • Perioperative and device- and/or procedure-related adverse events
2-week	• Device- and/or procedure-related adverse events
3-month	• GERD-related medication usage within the last 30 days • GERD-HRQL (off PPIs) and Foregut Symptoms Questionnaire (off PPIs) • Device- and/or procedure-related adverse events
6-month	• GERD-related medication use within the last 30 days • GERD-HRQL (off PPIs) and Foregut Symptoms Questionnaire (off PPIs) • Device- and/or procedure-related adverse events
12-month	• Height and weight • GERD-HRQL (off PPIs) and Foregut Symptoms Questionnaire (off PPIs) • GERD-related medication usage within the last 30 days • Esophageal pH testing (off PPIs) • Manometry/motility • Endoscopy • Barium esophagram and upright Bi-Planar X-Rays • Device- and/or procedure-related adverse events