CompletedInterventionalNot ApplicableUpdated Mar 17, 2023
Clinical Investigation of Non Invasive Fat Reduction | NCT01842802 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 28, 2020
Clinical Investigation of Non Invasive Fat Reduction
ClinicalTrials.gov ID
NCT01842802
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
8Actual
Last Update Posted
Oct 28, 2020Actual
Start Date
Jan 2012
Primary Completion Date
Aug 2013Actual
Completion Date
Aug 2013Actual
Brief Summary
The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.
Subcutaneous Fat
Diode Laser
YAG laser
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A healthy non-smoking male or female between 20-60 years of age
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 will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
Understand and accept the obligation associated with the procedure
Subjects with Fitzpatrick skin types I to III.
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.
Subjects must agree to maintain the same diet and exercise regime throughout the study
Exclusion Criteria:
Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
A history of allergic reactions to medications or anesthesia required for the procedure
A history of thrombophlebitis
A history of acute infections
A history of heart failure
Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
Intolerance to anesthesia or medications to be prescribed before or after the procedure.
Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study including EMLA cream or percocet
Taking medications that are photosensitive
A history of keloid formation
A study subject must not be pregnant or have been pregnant in the last 3 months
The physician has the right to make determination of eligibility as he/she deems clinically significant based on standard of care treatment