Obalon US Commercial Registry

September 26, 2018 updated by: Surgical Specialists of Louisiana

Obalon Balloon System: Real-World Evidence Commercial Site Registry

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obalon Commercial Patients

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgical Specialists of Louisiana

Collaborators

Obalon Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

August 28, 2018

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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