Status:
COMPLETED
Clinical Evaluation of CelluTite Treatment
Lead Sponsor:
InMode MD Ltd.
Conditions:
Cellulite of Thighs
Eligibility:
FEMALE
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03769649
Start Date
November 12 2018
End Date
January 17 2020
Last Update
June 8 2022
Active Locations (1)
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1
Juva
New York, New York, United States, 10022