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Evaluation of the Safety and Precursors of Efficacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098811
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Tracking Information
First Submitted Date  ICMJE March 25, 2014
First Posted Date  ICMJE March 28, 2014
Last Update Posted Date October 27, 2020
Study Start Date  ICMJE June 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
  • Biopsy of Tissue Sample as a Measure of Effectiveness [ Time Frame: 6 months post treatment ]
    Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device
  • Ultrasound Measurement to Evaluate Reduction of Fat [ Time Frame: 6 months post treatment ]
    Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
High Frequency Ultrasound to Measure Skin Elasticity and Thickness [ Time Frame: 6 months post last treatment ]
High frequency ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to measure changes in skin elasticity and skin thickness.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety and Precursors of Efficacy
Official Title  ICMJE Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths
Brief Summary The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
Detailed Description The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Subcutaneous Fat
Intervention  ICMJE
  • Device: 1064nm Laser
    Patient will be treated with 1064nm Laser prior to abdominoplasty
  • Device: 940nm Laser
    Patient will be treated with 940nm Laser prior to abdominoplasty
Study Arms  ICMJE
  • Experimental: 1064nm laser Treatment Before Abdominoplasty
    Patient will be treated with 1064nm Laser prior to abdominoplasty
    Intervention: Device: 1064nm Laser
  • Experimental: 940nm Laser Treatment Before Abdominoplasty
    Patient will be treated with 940nm Laser prior to abdominoplasty
    Intervention: Device: 940nm Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
11
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-smoking subjects between ages of 20-55 years of age 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 (Group 2 and 3) 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 VI.
  • Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, 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
  • 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 determines based on the standard of care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02098811
Other Study ID Numbers  ICMJE CYN13-NIF-JD-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynosure, Inc.
Study Sponsor  ICMJE Cynosure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patric Krantz Cynosure, Inc.
PRS Account Cynosure, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP