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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Control
• Intervention / Treatment: Device: Obalon Gastric Balloon

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 6B1070
    • Department of Gastroenterology, Erasme Hospital
• France
  • Cedex
    • Lyon, Cedex, France, 69473
      • Service D'exploration Functionelle Digestive, Hospital Edouard Harriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Excess Weight Loss based on an ideal BMI of 25.	12 weeks
Assessment of all adverse events.	12 weeks

Collaborators and Investigators

• Sponsor: Obalon Therapeutics, Inc.
• Investigators: Principal Investigator: Fancois Mion, MD, Hospital Edouard Harriot; Principal Investigator: Jacques Deviere, Erasme hospital

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Weight control; Intragastric balloon; gastric balloon
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: PTL-1000-0018