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Safety and Efficacy of the SMART Device for Overweight and Obese Adults
NCT02119299 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE SMART device
Study Locations (4)
California
- Investigative Site — San Diego
Connecticut
- Investigative Site — Waterbury
Florida
- Investigative Site — Coral Gables
Texas
- Investigative Site — Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02119299
The ClinicalTrials.gov registry entry for NCT02119299 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scientific Intake Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Overweight and Obesity appearing as the primary indexed condition, and to 1 intervention — of which SMART device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02119299 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02119299 about?
NCT02119299 is a clinical study titled "Safety and Efficacy of the SMART Device for Overweight and Obese Adults". 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 Proto...
What is the current status of trial NCT02119299?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2014-03. Estimated completion is 2015-01.
What conditions does trial NCT02119299 study?
This clinical trial studies the following conditions: Overweight and Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02119299?
The interventions under investigation include: SMART device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02119299?
This trial is sponsored by Scientific Intake Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02119299 being conducted?
This trial has 4 study locations across California, Connecticut, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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