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Safety and Efficacy of the SMART Device for Overweight and Obese Adults

NCT02119299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2017-07-17

Study results available
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Summary

The purpose of this study is to demonstrate that (1) we will observe at least 40% of the subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared to Week 0 is ≥4% in the Per Protocol population.

Conditions

  • Overweight and Obesity

Interventions

DEVICE

SMART device

Sensor Monitored Alimentary Restriction Therapy (SMART) device

Sponsors & Collaborators

  • Scientific Intake Limited Co.

    lead INDUSTRY

Principal Investigators

  • William H Longley · Scientific Intake

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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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 NCT02119299 on ClinicalTrials.gov