Obalon Balloon System Post-Approval Study (PAS)

Obalon Therapeutics

Status: Unknown

Conditions: Obesity

Treatments: Device: Obalon Balloon System

Study type: Observational

Funder types: Industry

Identifiers

NCT03570034

PTL-7500-0011

Details and patient eligibility

About

The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

Full description

The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal

Enrollment: 201 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 22 years old
• BMI of 30-40 kg/m2

Exclusion criteria

• Contraindicated for the device
• Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
• Known history of endocrine disorders affecting weight.
• Participation in any clinical study which could affect weight loss within the past year
• Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
• Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator

Trial design

201 participants in 1 patient group

Obalon Balloon System

Description:

Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program

Treatment:

Device: Obalon Balloon System