Obesity
Conditions
Keywords
Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia
Brief summary
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
* 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.
Interventions
DEVICEePass
Subject is implanted with the device for up to 3 years.
Sponsors
ValenTx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011. | 1 Year | The proportion of subjects affected by SADEs during the 12 months following their device implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Weight Loss in Kilograms | 1 Year | Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit. |
Countries
Argentina, Mexico
Outcome results
None listed