The ePass Clinical Trial for the Treatment of Obese Subjects
NCT02954016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-11-03
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.
Conditions
Interventions
- DEVICE
-
ePass
Subject is implanted with the device for up to 3 years.
Sponsors & Collaborators
-
ValenTx, Inc.
lead INDUSTRY
Principal Investigators
-
Roland Maude-Griffin · ValenTx, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2021-03-31
- Completion
- 2022-03-31
Countries
- Argentina
- Mexico
Study Locations
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