Clinical trial NCT03570034: Obalon Balloon System Post-Approval Study
Official title: Obalon Balloon System - Post-Approval Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Obalon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 201
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients aged 22 years and older, who are considered obesity Class I or II with a BMI of 30.0-40.0 kg/m2; and, have failed to lose weight through diet and exercise
* Patients willing to commercially purchase the device.

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Event
timeFrame: 6-Month
measure: Percentage of Patients with at least 5% TBWL
timeFrame: 6-Month
measure: Mean % TBWL
timeFrame: 6-Month
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Smart Dimensions Weight Loss
state: California
city: Glendale
country: United States
facility: Davtyan Medical Weight Loss and Wellness
state: California
city: Los Gatos
country: United States
facility: Lifetime Surgical Weight Loss
state: California
city: Santa Monica
country: United States
facility: SkyLex Health
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Springfield
country: United States
facility: New Jersey Bariatric Center
state: New Jersey
city: Poughkeepsie
country: United States
facility: Greenwich Village Gastroenterology
state: New York
city: Roslyn Heights
country: United States
facility: New York Bariatric Group
state: New York
city: Cincinnati
country: United States
facility: JourneyLite Physicians
state: Ohio
city: Toledo
country: United States
facility: Artisan Cosmetic Surgery
state: Ohio
city: Dallas
country: United States
facility: Minimally Invasive Surgical Associates
state: Texas
city: Flower Mound
country: United States
facility: Snow Bariatic Center
state: Texas
city: Fort Worth
country: United States
facility: Ultimate Bariatrics
state: Texas
city: San Antonio
country: United States
facility: Bariatric Medical Institute of Texas
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Shelby Sullivan, MD, FACG
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgical Specialist of Louisiana
name: Rachel Moore, MD, FACS, FASMBS
role: PRINCIPAL_INVESTIGATOR
References: