The ePass Clinical Trial for the Treatment of Obese Subjects
NCT ID: NCT02954016
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-03-31
2022-03-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ePass
Subjects implanted with the investigational ValenTx Endo Bypass System
ePass
Subject is implanted with the device for up to 3 years.
Interventions
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ePass
Subject is implanted with the device for up to 3 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Past history of esophageal, gastric or bariatric surgery.
* Medical conditions contraindicating elective endoscopic or bariatric procedures.
* Insulin-dependent diabetes mellitus
18 Years
60 Years
ALL
Yes
Sponsors
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ValenTx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roland Maude-Griffin
Role: STUDY_DIRECTOR
ValenTx, Inc.
Locations
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Hospital Italiano de Mendoza / Clinica Quiriurgica
Mendoza, , Argentina
Swiss Hospital / Especialidades Bariatrices
Monterrey, Nuevo León, Mexico
Countries
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Other Identifiers
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EP 1.0
Identifier Type: -
Identifier Source: org_study_id