Obalon US Commercial Registry

Surgical Specialists of Louisiana1,343 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,343

Conditions

Obesity

Interventions

Obalon Balloon SystemDEVICE

6 month Obalon Intragastric Balloons

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Started Obalon Balloon Therapy between Jan.-Dec. 2017 * Weight loss data through balloon removal * BMI \>25kg/m2

Outcomes

Primary Outcomes

Primary Safety Outcome - Serious Adverse Events

Percentage of Patients with Serious Adverse Events

Time frame: 6 months

Primary Effectiveness Outcome - Weight Loss Metrics

Mean Weight Loss Metrics

Time frame: 6 months

Data from ClinicalTrials.gov

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