Clinical Evaluation of RFAL of Breast Envelope and NAC Position

NCT ID: NCT03863834

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-13
• Study Completion Date: 2020-04-01

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)

Conditions

Breast Lift

Study Design

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

Study Groups

Treatment arm

Subjects receive the RFAL treatment

Group Type: EXPERIMENTAL

InModeRF

Intervention Type: DEVICE

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

Interventions

InModeRF

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Unger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Jacob G Unger MD

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D0607738

Identifier Type: -

Identifier Source: org_study_id