NCT01842802

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

April 26, 2013

Last Update Submit

October 27, 2020

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Lipid level blood testing to evaluate changes post treatment

    5 months post treatment

Study Arms (2)

Diode Laser Treatment Before Abdominoplasty

EXPERIMENTAL

Patient will be treated with Diode Laser prior to abdominoplasty.

Device: Diode Laser

YAG Laser Treatment Before Abdominoplasty

EXPERIMENTAL

Patients will be treated with YAG prior to abdominoplasty

Device: YAG laser

Interventions

Diode LaserDEVICE

Diode Laser for treatment of subcutaneous fat

Diode Laser Treatment Before Abdominoplasty
YAG laserDEVICE

YAG laser for treatment of subcutaneous fat

YAG Laser Treatment Before Abdominoplasty

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aesthetic Pavilion

Staten Island, New York, 10306, United States

Location

MeSH Terms

Interventions

Lasers, SemiconductorLasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Patricia Krantz

    Cynosure, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

US(1)