PROMISEPrimary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial

The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures. The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure. Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months. Secondary Endpoints: Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss (%EWL) Total weight lost (kg) and percent weight lost Change in (BMI) and percent change in BMI Change in waist circumference Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline) Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline) Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.