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NCT03570034 Clinical Trial

Obalon Balloon System Post-Approval Study

Obesity Clinical Trial

— PAS  

Official title:
Obalon Balloon System - Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03570034
Other study ID # PTL-7500-0011
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 15, 2018
Est. completion date March 13, 2021

Study information
Verified date April 2020
Source Obalon Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 201
Est. completion date March 13, 2021
Est. primary completion date September 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Obalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado
United States JourneyLite Physicians Cincinnati 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 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 Surgical Specialists of Louisiana Metairie Louisiana
United States Greenwich Village Gastroenterology Poughkeepsie New York
United States New York Bariatric Group Roslyn Heights New York
United States Bariatric Medical Institute of Texas San Antonio Texas
United States SkyLex Health Santa Monica California
United States New Jersey Bariatric Center Springfield New Jersey
United States Artisan Cosmetic Surgery Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
Obalon Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serious Adverse Event Device or Procedure related Serious Adverse Event 6-Month
Primary Percentage of Patients with at least 5% TBWL Percentage of Patients with at least 5% TBWL 6-Month
Primary Mean % TBWL Mean %TBWL 6-Month
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