A Single Centre 30-day Observational Non-randomised Study to Evaluate Preliminary Safety and Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

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

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Obalon Therapeutics, Inc.
Enrollment: 10
Locations: 1
Status: Completed
Last Updated: 13 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

January 2011

End Date

March 2011

Last Updated

13 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);