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
40 participants
INTERVENTIONAL
2013-12-31
2018-10-31
Brief Summary
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Detailed Description
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* 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.
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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Endo Bypass
Subjects implanted with the investigational ValenTx Endo Bypass System
Endo Bypass System
Subject is implanted with the device for up to 3 years.
Interventions
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Endo Bypass System
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
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
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.
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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St. Joseph Healthcare
Hamilton, Ontario, Canada
Hopital Laval (IUCPQ)
Québec, Quebec, Canada
Hospital San Jose Tec de Monterrey
Monterrey, Nuevo León, Mexico
Countries
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Other Identifiers
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EN 2.3
Identifier Type: -
Identifier Source: org_study_id