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Obalon Balloon System Post-Approval Study (PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570034
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.

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

Condition or disease Intervention/treatment
Obesity 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

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Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Obalon Balloon System - Post-Approval Study
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : September 13, 2020
Estimated Study Completion Date : March 13, 2021

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




Primary Outcome Measures :
  1. Serious Adverse Event [ Time Frame: 6-Month ]
    Device or Procedure related Serious Adverse Event

  2. Percentage of Patients with at least 5% TBWL [ Time Frame: 6-Month ]
    Percentage of Patients with at least 5% TBWL

  3. Mean % TBWL [ Time Frame: 6-Month ]
    Mean %TBWL



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570034


Locations
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United States, California
Smart Dimensions Weight Loss
Fountain Valley, California, United States, 92694
Davtyan Medical Weight Loss and Wellness
Glendale, California, United States, 91202
Lifetime Surgical Weight Loss
Los Gatos, California, United States, 95032
SkyLex Health
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Louisiana
Surgical Specialists of Louisiana
Metairie, Louisiana, United States, 70001
United States, New Jersey
New Jersey Bariatric Center
Springfield, New Jersey, United States, 07081
United States, New York
Greenwich Village Gastroenterology
Poughkeepsie, New York, United States, 12601
New York Bariatric Group
Roslyn Heights, New York, United States, 11577
United States, Ohio
JourneyLite Physicians
Cincinnati, Ohio, United States, 45241
Artisan Cosmetic Surgery
Toledo, Ohio, United States, 43617
United States, Texas
Minimally Invasive Surgical Associates
Dallas, Texas, United States, 75208
Snow Bariatic Center
Flower Mound, Texas, United States, 75028
Ultimate Bariatrics
Fort Worth, Texas, United States, 76102
Bariatric Medical Institute of Texas
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Obalon Therapeutics, Inc.
Investigators
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Principal Investigator: Shelby Sullivan, MD, FACG University of Colorado, Denver
Principal Investigator: Rachel Moore, MD, FACS, FASMBS Surgical Specialist of Louisiana
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Responsible Party: Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03570034    
Other Study ID Numbers: PTL-7500-0011
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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