Clinical Evaluation of RFAL of Breast Envelope and NAC Position

NCT03863834 | Completed Results FDA Device

• 1 other identifier: D0607738
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Lift

Outcome Measures

Primary Outcomes (2)

• Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)

  Regular and 3D Vectra photos will be taken at all time points. Additional evaluation of changes in breast shape, including upper pole fullness, breast projection, and bottoming out will be assessed by static measurements (cm) of: * Sternal Notch to Nipple * Nipple to Inframammary Fold (IMF) * Base Width (at point of breast take off from chest wall) * Nipple to nipple

  12 months

• Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.

  Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatment 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.

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Subjects receive the RFAL treatment

Device: InModeRF

Interventions

InModeRF DEVICE

InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology

Treatment arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (1)

Jacob G Unger MD

Nashville, Tennessee, 37212, United States

Location

Results Point of Contact

• Title: Maria Shusterman, Clinical Director
• Organization: Inmode Ltd

maria.shusterman@inmodemd.com

9057070975

Study Officials

• Jacob Unger, MD

  Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive the treatment and outcome will be followed

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: October 13, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 16, 2022
• Results First Posted: August 16, 2022

Record last verified: 2021-02

Locations

US (1)