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Clinical Evaluation of CelluTite Treatment

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ClinicalTrials.gov Identifier: NCT03769649
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Brief Summary:
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.

Condition or disease Intervention/treatment Phase
Cellulite of Thighs Device: CelluTite Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Treatment arm
Subjects receive CelluTite treatment followed by Morpheus8 treatment
Device: CelluTite
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other Name: Morpheus8




Primary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769649


Contacts
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Contact: Janet Handley 855.411.2639 Janet.Handley@inmodemd.com
Contact: Maureen Abdulla +1.949.305.0106 maureen.abdulla@inmodemd.com

Locations
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United States, New York
Dr. Obaid Chaudhry Recruiting
New York, New York, United States, 10019
Contact: Obaid Chaudhry, M.D         
Principal Investigator: Obaid Chaudhry         
Sponsors and Collaborators
InMode MD Ltd.
Investigators
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Principal Investigator: Obaid Chaudhry, MD 128 Central Park S #1c, New York, NY 10019, USA

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Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT03769649     History of Changes
Other Study ID Numbers: DO608110
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Signs and Symptoms