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Clinical Evaluation of CelluTite Treatment

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: NCT03769649
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Reduction in cellulite score rated according to Cellulite severity scale at follow- up visits comparing to baseline score. [ Time Frame: 7 months ]
    Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). This 5-point photonumeric scale rates cellulite severity from a score "0" (none) to "4" (severe) from a clinician's perspective in two main clinical morphologic features of cellulite (categories): (A) number of evident dimples; and (B) severity of linear undulations. Cellulite score is a given based on a combination of the two characteristics: number of dimples and severity of modulations. Score reduction at follow-up visit comparing to baseline indicates that treatment is effective.
  • Occurrence of adverse events will be assessed based on frequency, severity and causality data. [ Time Frame: 7 months ]
    Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatments and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of CelluTite Treatment
Official Title  ICMJE Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
Brief Summary This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
Detailed Description

The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:

  • The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode.
  • The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cellulite of Thighs
Intervention  ICMJE Device: CelluTite
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other Name: Morpheus8
Study Arms  ICMJE Experimental: Treatment arm
Subjects receive CelluTite treatment followed by Morpheus8 treatment
Intervention: Device: CelluTite
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: September 23, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
40
Actual Study Completion Date  ICMJE January 17, 2020
Actual Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects aged 18-70 having mild/moderate grade cellulites.
  • The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
  • The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods in the treatment area for the last 6 months and during the entire study period.

Exclusion Criteria:

  • Body fat layer thinner than 5mm.
  • Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
  • Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
  • Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
  • Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
  • Pregnancy and nursing.
  • History of bleeding coagulopathies or use of anticoagulants.
  • Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
  • Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
  • Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
  • History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
  • Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
  • Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
  • Allergies, in particular to anesthesia.
  • Mental disorders such as Body Dysmorphic Disorder (BDD).
  • As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03769649
Other Study ID Numbers  ICMJE DO608110
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InMode MD Ltd.
Study Sponsor  ICMJE InMode MD Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Katz, MD 60 E 56th St #2, New York, NY 10022, USA
PRS Account InMode MD Ltd.
Verification Date September 2019

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