Completed
Clinical Investigation of Non Invasive Fat Reduction
What is being tested
Diode Laser
+ YAG laser
Device
Who is being recruted
From 20 to 60 Years
+19 Eligibility Criteria
How is the trial designed
Device Feasibility Study
Interventional
Study Start: January 2012
Summary
Principal SponsorCynosure, Inc.
Last updated: October 28, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.
Principal SponsorCynosure, Inc.
Last updated: October 28, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 20 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
A healthy non-smoking male or female between 20-60 years of age
Subjects must agree to maintain the same diet and exercise regime throughout the study
Subjects presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing as outlined for each group and defined in section 6.0
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12 exclusion criteria prevent from participating
A history of acute infections
A history of allergic reactions to medications or anesthesia required for the procedure
A history of heart failure
A history of keloid formation
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatient will be treated with Diode Laser prior to abdominoplasty.
Group II
ExperimentalPatients will be treated with YAG prior to abdominoplasty
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center