The ePass Clinical Trial for the Treatment of Obese Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: ePass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ePass<br>Subjects implanted with the investigational ValenTx Endo Bypass System | Device: ePass<br>* Subject is implanted with the device for up to 3 years.<br>* Other names: EBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011. | The proportion of subjects affected by SADEs during the 12 months following their device implant | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 Month Weight Loss in Kilograms | Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia