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OpenTrials
Completed

NCT Number: NCT01842802

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aesthetic Pavilion

Staten Island, New York, 10306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diode laser

Device

Diode Laser for treatment of subcutaneous fat

YAG laser

Device

YAG laser for treatment of subcutaneous fat

Primary outcomes

  1. Biopsy of Tissue Samples as a Measure of Effectiveness

    Time frame: 5 months post treatment

    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.

  2. Ultrasound Measurement to Evaluate Reduction of Fat

    Time frame: 5 months post treatment

    Ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to determine reduction of the subcutaneous fat layer.

Secondary outcomes

  1. Lipid level blood testing to evaluate changes post treatment

    Time frame: 5 months post treatment

    Blood testing will be performed to evaluate changes in lipid levels post treatment

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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