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Obalon Balloon System Pivotal IDE (SMART) Trial

NCT02235870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2018-03-08

Study results available
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Summary

This pivotal trial of the Obalon Balloon System is intended to generate safety and effectiveness data required to support a future marketing application. The trial has been designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition and lifestyle behavior modification program.

Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.

Conditions

Interventions

DEVICE

Obalon Intragastric Balloons

Intragastric Balloon System to aid in portion control.

DEVICE

Sham Device

Sham Intragastric Balloon

BEHAVIORAL

Nutrition and Lifestyle Program

Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.

Sponsors & Collaborators

  • Obalon Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amy VandenBerg · Obalon Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-11-30
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02235870 on ClinicalTrials.gov