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Obalon US Commercial Registry

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: NCT03688256
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Obalon Therapeutics, Inc.
Information provided by (Responsible Party):
Surgical Specialists of Louisiana

Brief Summary:
Retrospective study of the data reported in the Obalon US Commercial Registry

Condition or disease Intervention/treatment
Obesity Device: Obalon Balloon System

Detailed Description:
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1343 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Obalon Balloon System: Real-World Evidence Commercial Site Registry
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Intervention Details:
  • Device: Obalon Balloon System
    6 month Obalon Intragastric Balloons


Primary Outcome Measures :
  1. Primary Safety Outcome - Serious Adverse Events [ Time Frame: 6 months ]
    Percentage of Patients with Serious Adverse Events

  2. Primary Effectiveness Outcome - Weight Loss Metrics [ Time Frame: 6 months ]
    Mean Weight Loss Metrics



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obalon Commercial Patients
Criteria

Inclusion Criteria:

  • Started Obalon Balloon Therapy between Jan.-Dec. 2017
  • Weight loss data through balloon removal
  • BMI >25kg/m2
Additional Information:

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Responsible Party: Surgical Specialists of Louisiana
ClinicalTrials.gov Identifier: NCT03688256    
Other Study ID Numbers: 01
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
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