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

Sponsor

Obalon Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01718886

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Obesity Weight Control	Device: Obalon Gastric Balloon

Study Design

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 :

Jan 1, 2012

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Obalon Gastric Balloon

Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks

Device: Obalon Gastric Balloon

Outcome Measures

Primary Outcome Measures

Percent Excess Weight Loss based on an ideal BMI of 25. [12 weeks]
Assessment of all adverse events. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Erasme Hospital	Brussels		Belgium	6B1070
2	Service D'exploration Functionelle Digestive, Hospital Edouard Harriot	Lyon	Cedex	France	69473