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NCT03688256 Clinical Trial

Obalon US Commercial Registry

Obesity Clinical Trial

Official title:
Obalon Balloon System: Real-World Evidence Commercial Site Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03688256
Other study ID # 01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date August 28, 2018

Study information
Verified date September 2018
Source Surgical Specialists of Louisiana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Retrospective study of the data reported in the Obalon US Commercial Registry

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.

Recruitment information / eligibility
Status Completed
Enrollment 1343
Est. completion date August 28, 2018
Est. primary completion date August 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Started Obalon Balloon Therapy between Jan.-Dec. 2017

- Weight loss data through balloon removal

- BMI >25kg/m2

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Obalon Balloon System
6 month Obalon Intragastric Balloons

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Surgical Specialists of Louisiana Obalon Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Safety Outcome - Serious Adverse Events Percentage of Patients with Serious Adverse Events 6 months
Primary Primary Effectiveness Outcome - Weight Loss Metrics Mean Weight Loss Metrics 6 months
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