Obesity
Conditions
Keywords
Obesity, Weight Loss
Brief summary
The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.
Detailed description
* Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months. * Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year. * Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire. * All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant. * Subject 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 based on the condition of the implanted device.
Interventions
DEVICEEndo Bypass System
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
1. Between 18- 60 years old. 2. BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes 3. Willing to give informed consent, and able to understand what this means. 4. Documented failure with non-surgical weight loss methods. 5. Willing to follow the study procedures and comply with the visits schedule. 6. Live within a reasonable distance of the research center and be able to attend routine follow up visits.
Exclusion criteria
1. Pregnancy or intention to become pregnant during the course of the study. 2. Abnormal screening esophagogastroduodenoscopy findings 3. Prior esophageal, gastric or bariatric surgery. 4. Known allergies to any of the device materials. 5. Use of weight loss drugs, stimulants and/or herbal weight loss supplements. 6. Recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine. 7. Participation in another clinical trial within 60 days of the implant. 8. Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.
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 |
|---|---|---|
| Mean 12 Month Weight Loss in Kilograms | 1 Year | Mean reduction in bodyweight in kilograms from the pre-implant baseline visit to the 12 month post-implant follow-up visit. |
Countries
Canada, Mexico
Outcome results
None listed