Clinical Investigation of Non Invasive Fat Reduction

Cynosure

Status: Completed

Conditions: Subcutaneous Fat

Treatments: Device: Diode Laser; Device: YAG laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842802

CYN12-NIF-ABDM02

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Diode Laser Treatment Before Abdominoplasty

Experimental group

Description:

Patient will be treated with Diode Laser prior to abdominoplasty.

Treatment:

Device: Diode Laser

YAG Laser Treatment Before Abdominoplasty

Experimental group

Description:

Patients will be treated with YAG prior to abdominoplasty

Treatment:

Device: YAG laser