Obalon Balloon System Post-Approval Study

Status unconfirmed

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT03570034

Run by

Obalon Therapeutics, Inc.

People needed

201

Starts

2018-06-15

Expected to finish

2021-03-13

Last updated by the study team

2020-04-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Smart Dimensions Weight Loss — Fountain Valley, California, United States
• Davtyan Medical Weight Loss and Wellness — Glendale, California, United States
• Lifetime Surgical Weight Loss — Los Gatos, California, United States
• SkyLex Health — Santa Monica, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Surgical Specialists of Louisiana — Metairie, Louisiana, United States
• New Jersey Bariatric Center — Springfield, New Jersey, United States
• Greenwich Village Gastroenterology — Poughkeepsie, New York, United States
• New York Bariatric Group — Roslyn Heights, New York, United States
• JourneyLite Physicians — Cincinnati, Ohio, United States
• Artisan Cosmetic Surgery — Toledo, Ohio, United States
• Minimally Invasive Surgical Associates — Dallas, Texas, United States
• Snow Bariatic Center — Flower Mound, Texas, United States
• Ultimate Bariatrics — Fort Worth, Texas, United States
• Bariatric Medical Institute of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.