Skip to main content
OpenTrials
Completed

NCT Number: NCT03688256

Obalon US Commercial Registry

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Obalon Balloon System

Device

6 month Obalon Intragastric Balloons

Primary outcomes

  1. Primary Safety Outcome - Serious Adverse Events

    Time frame: 6 months

    Percentage of Patients with Serious Adverse Events

  2. Primary Effectiveness Outcome - Weight Loss Metrics

    Time frame: 6 months

    Mean Weight Loss Metrics

Sponsors and collaborators

Lead sponsor

Surgical Specialists of Louisiana

Other

Collaborators

  • Obalon Therapeutics, Inc.

Registry information

Official study title

Obalon Balloon System: Real-World Evidence Commercial Site Registry

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2018
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.