Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
112 participants
OBSERVATIONAL
2009-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Easyband
Subjects who had the Easyband device implanted laparoscopically.
Easyband®
The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.
Interventions
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Easyband®
The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and \< 40 kg/m2 with one or more significant medical conditions related to obesity
Exclusion Criteria
* patients who are not indicated for laparoscopic bariatric surgery
* patients with known allergies to implant materials such as silicone and PEEK
* patients whose abdominal structures have been damaged during preceding surgical procedures
* pregnant women
* patients under the age of 18 years
* patients treated with steroids
* patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
* patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc
18 Years
ALL
No
Sponsors
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Allergan Medical
INDUSTRY
Responsible Party
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Locations
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Brussels, , Belgium
Peschiera, , Italy
Nieuwegein, , Netherlands
Cheshire, , United Kingdom
Countries
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Other Identifiers
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CIP10088
Identifier Type: -
Identifier Source: org_study_id
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