European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
NCT ID: NCT01718886
Last Updated: 2012-10-31
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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COMPLETED
17 participants
OBSERVATIONAL
2012-01-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Obalon Gastric Balloon
Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks
Obalon Gastric Balloon
Interventions
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Obalon Gastric Balloon
Eligibility Criteria
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Inclusion Criteria
* Had a BMI 27-35 Kg/cm
* Did not have a history of weight reduction over 5% of body weight over the past 6 months
* Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing
* Were able to understand and willing to provide written informed consent
Exclusion Criteria
* Had unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
* Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
* Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months;
* Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;
* Had a history or symptoms of thyroid disease which is not controlled by medication;
* Had severe renal, hepatic, pulmonary disease or cancer;
* Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
* Had any abnormal stenosis or obstruction of the GI tract;
* Had a history of adhesive peritonitis;
* Had a previously diagnosed hiatal hernia greater than 2cm;
* Had any abnormality of the esophagus, stomach or pylorus;
* Had history of severe esophagitis;
* Had history or symptoms of esophageal and/or gastric varices;
* Had history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
* Had history or symptoms of inflammatory bowel disease, such as Chron's disease;
* Had history of/ signs and /or symptoms of duodenal or gastric ulcer;
* Untreated H.Pylori
* Had history or signs of dysphasia, achalasia or symptoms of or GI motility;
* Were undergoing chronic steroid or immunosuppressive therapy;
* Were pregnant or breastfeeding or had the intention of becoming pregnant during the study;
* Had placement of previous intragastric balloon or similar device;
* Were using pharmaceutical agents for weight loss;
* Were drinking alcohol in excess or using illicit drugs;
* Had bulimia or binge eating disorders;
* Had impending gastric surgery 30 days post balloon removal;
* Had planned flying or scuba diving activities during balloon residence time;
* Had any other condition that, in the opinion of the investigator, would interfere with their participation and compliance with the study (i.e. psychosocial issues);
* Were participating in other investigational study protocols. If a subject had recently completed participation in another drug or device study, the subject must have completed that study at least 30 days prior to being enrolled in this study;
* Had history or known allergies to any component of the device materials, including but not limited to allergies to porcine proteins.
21 Years
64 Years
ALL
No
Sponsors
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Obalon Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fancois Mion, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Edouard Harriot
Jacques Deviere
Role: PRINCIPAL_INVESTIGATOR
Erasme hospital
Locations
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Department of Gastroenterology, Erasme Hospital
Brussels, , Belgium
Service D'exploration Functionelle Digestive, Hospital Edouard Harriot
Lyon, Cedex, France
Countries
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Related Links
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Sponsor's website
Other Identifiers
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PTL-1000-0018
Identifier Type: -
Identifier Source: org_study_id