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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.

Tracking Information
First Submitted Date June 15, 2018
First Posted Date June 26, 2018
Last Update Posted Date April 30, 2020
Actual Study Start Date June 15, 2018
Estimated Primary Completion Date September 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2018)
  • Serious Adverse Event [ Time Frame: 6-Month ]
    Device or Procedure related Serious Adverse Event
  • Percentage of Patients with at least 5% TBWL [ Time Frame: 6-Month ]
    Percentage of Patients with at least 5% TBWL
  • Mean % TBWL [ Time Frame: 6-Month ]
    Mean %TBWL
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obalon Balloon System Post-Approval Study
Official Title Obalon Balloon System - Post-Approval Study
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Obesity
Intervention Device: Obalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
Study Groups/Cohorts Obalon Balloon System
Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program
Intervention: Device: Obalon Balloon System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 29, 2020)
201
Original Estimated Enrollment
 (submitted: June 15, 2018)
200
Estimated Study Completion Date March 13, 2021
Estimated Primary Completion Date September 13, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03570034
Other Study ID Numbers PTL-7500-0011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Obalon Therapeutics, Inc.
Study Sponsor Obalon Therapeutics, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Shelby Sullivan, MD, FACG University of Colorado, Denver
Principal Investigator: Rachel Moore, MD, FACS, FASMBS Surgical Specialist of Louisiana
PRS Account Obalon Therapeutics, Inc.
Verification Date April 2020