At a glance
ClinicalIndex Comparison RecordN/ACompleted· 76 enrolled
Drug / intervention
SMART devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Single Arm, Multicenter Study Evaluating the Safety and Weight Loss Efficacy of the SMART Device + DVD Weight Loss Education for Overweight and Obese Adults
In Brief
A clinical study evaluating SMART device for Overweight and Obesity. Completed, enrolled 76 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight and Obesity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedApr 2014
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedApr 21, 2014
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago
Interventions
SMART devicedevice
Sensor Monitored Alimentary Restriction Therapy (SMART) device