Obalon Balloon System Post-Approval Study (PAS)

Obalon Balloon System - Post-Approval Study

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

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: Obalon Balloon System

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

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92694
      • Smart Dimensions Weight Loss
    • Glendale, California, United States, 91202
      • Davtyan Medical Weight Loss and Wellness
    • Los Gatos, California, United States, 95032
      • Lifetime Surgical Weight Loss
    • Santa Monica, California, United States, 90404
      • SkyLex Health
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Surgical Specialists of Louisiana
  • New Jersey
    • Springfield, New Jersey, United States, 07081
      • New Jersey Bariatric Center
  • New York
    • Poughkeepsie, New York, United States, 12601
      • Greenwich Village Gastroenterology
    • Roslyn Heights, New York, United States, 11577
      • New York Bariatric Group
  • Ohio
    • Cincinnati, Ohio, United States, 45241
      • JourneyLite Physicians
    • Toledo, Ohio, United States, 43617
      • Artisan Cosmetic Surgery
  • Texas
    • Dallas, Texas, United States, 75208
      • Minimally Invasive Surgical Associates
    • Flower Mound, Texas, United States, 75028
      • Snow Bariatic Center
    • Fort Worth, Texas, United States, 76102
      • Ultimate Bariatrics
    • San Antonio, Texas, United States, 78258
      • Bariatric Medical Institute of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obalon Balloon System; Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program	Device: Obalon Balloon System; Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Obalon Therapeutics, Inc.
• Investigators: Principal Investigator: Shelby Sullivan, MD, FACG, University of Colorado, Denver; Principal Investigator: Rachel Moore, MD, FACS, FASMBS, Surgical Specialist of Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Anticipated): September 13, 2020
• Study Completion (Anticipated): March 13, 2021

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PTL-7500-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes