Obalon US Commercial Registry

Obalon Balloon System: Real-World Evidence Commercial Site Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03688256

Enrollment

1343

Registered

2018-09-28

Start date

2017-01-01

Completion date

2018-08-28

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

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.

Interventions

DEVICEObalon Balloon System

6 month Obalon Intragastric Balloons

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026