A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

Obalon Therapeutics, Inc.1 site in 1 country10 target enrollmentJuly 2011

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Obalon Therapeutics, Inc.
Enrollment: 10
Locations: 1
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

September 2011

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Obalon Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age between 21-64 years
•BMI 27-40 Kg/m2
•No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria

•Have 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;
•Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
•Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
•Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
•History or symptoms of thyroid disease which is not controlled by medication;
•Have severe renal, hepatic, pulmonary disease or cancer;
•Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
•Have a history of adhesive peritonitis;
•History or symptoms of esophageal and/or gastric varices;
•Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);