Clinical Evaluation of CelluTite Treatment

NCT ID: NCT03769649

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2020-01-17

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.

Conditions

Cellulite of Thighs

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Subjects receive CelluTite treatment followed by Morpheus8 treatment

Group Type: EXPERIMENTAL

CelluTite

Intervention Type: DEVICE

CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF

Interventions

CelluTite

CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF

Intervention Type: DEVICE

Other Intervention Names

Morpheus8

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Katz, MD

Role: PRINCIPAL_INVESTIGATOR

60 E 56th St #2, New York, NY 10022, USA

Locations

Juva

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DO608110

Identifier Type: -

Identifier Source: org_study_id