Clinical Investigation of Non Invasive Fat Reduction

Completed · Not applicable

Conditions studied: Subcutaneous Fat

In brief

The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.

Key facts

Study ID

NCT01842802

Run by

Cynosure, Inc.

People needed

8

Starts

2012-01-01

Expected to finish

2013-08-01

Last updated by the study team

2020-10-28

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aesthetic Pavilion — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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