Clinical trial NCT03769649: Clinical Evaluation of CelluTite Treatment
Official title: Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite of Thighs
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will receive the treatment and outcome will be followed
Primary purpose: 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.

Eligibility 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.

Primary outcomes:
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
timeFrame: 6 months
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
timeFrame: 6 months
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
timeFrame: 6 months
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
timeFrame: 1 month
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
timeFrame: 3 months
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
timeFrame: 1 month
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
timeFrame: 3 months
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
timeFrame: 1 week
measure: Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
timeFrame: 1 week
measure: Assessment of Adverse Events Occurrence Based on Severity
timeFrame: 3 months
measure: Assessment of Adverse Events Occurrence Based on Severity
timeFrame: 1 month
measure: Assessment of Adverse Events Occurrence Based on Severity
timeFrame: 1 week
measure: Assessment of Adverse Events Occurrence Based on Severity
timeFrame: Treatment Day
measure: Assessment of Adverse Events Occurrence Based on Severity
timeFrame: 6 Months
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
timeFrame: 3 months
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
timeFrame: 1 week
measure: Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
timeFrame: Treatment Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Juva
state: New York
Study officials:
affiliation: 60 E 56th St #2, New York, NY 10022, USA
name: Bruce Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: