The ePass Clinical Trial for the Treatment of Obese Subjects

Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial

To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.

The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

• Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
• Subjects will be implanted with the EndoPass device for up to 36 months.
• Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
• Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
• All subjects will be followed for 12 months after device removal.
• A single device renewal may take place as needed after the initial implant.
• Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Key Inclusion Criteria:

• 18-60 years of age.
• BMI ≥ 35 and ≤ 50 kg/m2
• Documented failure with non-surgical weight loss methods
• Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight

Key Exclusion Criteria:

• Pregnancy or intention of becoming pregnant.
• Past history of esophageal, gastric or bariatric surgery.
• Medical conditions contraindicating elective endoscopic or bariatric procedures.
• Insulin-dependent diabetes mellitus