CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Care as Usual Group +1 moredevice
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.

Search/NCT03811093
NCT03811093N/ACompleted
CompareCT.gov

Comparing the Efficacy of a Dual-Frequency Laser-Emitting Device, the "Invisared-RED Elite", With a Sham Device as Therapy for the Loss of Adipose Tissue (Body Fat) and Aesthetics in Overweight Individuals

IR Technology, LLC·interventional·Posted Jan 22, 2019·Updated Sep 15, 2022

In Brief

A clinical study evaluating Care as Usual Group and Sham Group for Obesity and 5 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The trial was designed to provide empirical evidence with which to compare the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham device as a placebo, when both are used in the treatment of individuals to reduce body fat and improve body aesthetics. At the conclusion of the trial; the change in body fat percentage, the change in total body fat in pounds, and total inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when used for body fat (adipose tissue) loss and/or aesthetics therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Body Weight, Fat Burn, Cellulite, Abdominal Fat, Adipose Tissue Atrophy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartJan 21, 2019
Primary CompletionFeb 9, 2019
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 7.4 years ago

Interventions

Care as Usual Groupdevice

Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.

Sham Groupdevice

Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.