Obalon US Commercial Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-08-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Obalon Balloon System

6 month Obalon Intragastric Balloons

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id