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

Obalon Therapeutics, Inc.2 sites in 2 countries17 target enrollmentJanuary 2012

ConditionsObesity Weight Control

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity
Sponsor: Obalon Therapeutics, Inc.
Enrollment: 17
Locations: 2
Primary Endpoint: Assessment of all adverse events.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

May 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Obalon Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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;