Clinical trial NCT03863834: Clinical Evaluation of RFAL of Breast Envelope and NAC Position
Official title: Clinical Evaluation of Safety and Efficacy of Radio-Frequency Assisted Lipolysis (RFAL) of Breast Envelope and Nipple-Areolar Complex (NAC) Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Lift
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: 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 single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)

Eligibility criteria: Inclusion Criteria:

* Informed consent agreement signed by the subject.
* Healthy females 21 to 60 years of age.
* Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.
* Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
* Willingness to follow the treatment and follow-up schedule and the post-treatment care.
* All participants must have a recorded mammogram before the beginning of the study.

Exclusion Criteria:

* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Permanent implant in the treated area such as metal plates and screws, 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.
* History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.
* 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.
* 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.
* Significant systemic illness or occult systemic illness.
* Illness, infection or skin diseases localized in area of treatment.
* Other therapies or medication which may interfere with treatment.
* Breastfeeding, pregnant, or planning to become pregnant during the study.
* Allergy to lidocaine or other anaesthesia.
* Recent surgery in treatment area within the past 6 months.
* Participation in a study of another device or drug within 3 months prior to enrolment or during this study.
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the patient to participate in this study.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.

Primary outcomes:
measure: Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)
timeFrame: 12 months
measure: Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Jacob G Unger MD
state: Tennessee
Study officials:
affiliation: Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA
name: Jacob Unger, MD
role: PRINCIPAL_INVESTIGATOR
References: