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Clinical Investigation of Non Invasive Fat Reduction

NCT ID: NCT01842802

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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Conditions

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Subcutaneous Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Diode Laser Treatment Before Abdominoplasty

Patient will be treated with Diode Laser prior to abdominoplasty.

Group Type EXPERIMENTAL

Diode Laser

Intervention Type DEVICE

Diode Laser for treatment of subcutaneous fat

YAG Laser Treatment Before Abdominoplasty

Patients will be treated with YAG prior to abdominoplasty

Group Type EXPERIMENTAL

YAG laser

Intervention Type DEVICE

YAG laser for treatment of subcutaneous fat

Interventions

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Diode Laser

Diode Laser for treatment of subcutaneous fat

Intervention Type DEVICE

YAG laser

YAG laser for treatment of subcutaneous fat

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

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Aesthetic Pavilion

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CYN12-NIF-ABDM02

Identifier Type: -

Identifier Source: org_study_id