Clinical Investigation of Non Invasive Fat Reduction

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

Study Overview

• Status: Completed
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Device: Diode Laser; Device: YAG laser

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10306
      • Aesthetic Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diode Laser Treatment Before Abdominoplasty; Patient will be treated with Diode Laser prior to abdominoplasty.	Device: Diode Laser; Diode Laser for treatment of subcutaneous fat
EXPERIMENTAL: YAG Laser Treatment Before Abdominoplasty; Patients will be treated with YAG prior to abdominoplasty	Device: YAG laser; YAG laser for treatment of subcutaneous fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsy of Tissue Samples as a Measure of Effectiveness	Biopsy of treated area will be obtained up to 5 months post treatment and will be histologically assessed for changes in adipocytes and surrounding tissue to determine effectiveness of device.	5 months post treatment
Ultrasound Measurement to Evaluate Reduction of Fat	Ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to determine reduction of the subcutaneous fat layer.	5 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid level blood testing to evaluate changes post treatment	Blood testing will be performed to evaluate changes in lipid levels post treatment	5 months post treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (ESTIMATE): April 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN12-NIF-ABDM02