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European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718886
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.

Brief Summary:
The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2

Condition or disease Intervention/treatment
Obesity Weight Control Device: Obalon Gastric Balloon

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Obalon Gastric Balloon
Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks
Device: Obalon Gastric Balloon

Primary Outcome Measures :
  1. Percent Excess Weight Loss based on an ideal BMI of 25. [ Time Frame: 12 weeks ]
  2. Assessment of all adverse events. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were selected from investigators' patient population and included patients with a BMI in the range of 27 - 35 kg/m^2

Inclusion Criteria:

  • Were between 21-64 years of age;
  • 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:

  • Experienced any difficulty in swallowing;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718886

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Department of Gastroenterology, Erasme Hospital
Brussels, Belgium, 6B1070
Service D'exploration Functionelle Digestive, Hospital Edouard Harriot
Lyon, Cedex, France, 69473
Sponsors and Collaborators
Obalon Therapeutics, Inc.
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Principal Investigator: Fancois Mion, MD Hospital Edouard Harriot
Principal Investigator: Jacques Deviere Erasme hospital
Additional Information:
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Responsible Party: Obalon Therapeutics, Inc. Identifier: NCT01718886    
Other Study ID Numbers: PTL-1000-0018
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012
Keywords provided by Obalon Therapeutics, Inc.:
Weight loss
Weight control
Intragastric balloon
gastric balloon
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes