Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas

Endymion Medical

Status

Completed

Conditions

Skin Wrinkling

Skin Aging

Treatments

Device: Device: EndyMed Pro System for Skin Tightening

Study type

Interventional

Funder types

Industry

Identifiers

NCT01029301

ED-IOP- 01

Details and patient eligibility

About

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis).

EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the EndyMed Pro system.

Enrollment

30 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females age 30 and up
Subjects with Fitzpatrick 4 to 9 degrees of elastosis
Subject able to comprehend and give informed consent for participation in this study
Subject must commit to all treatments and follow-up visits
Subject must sign the Informed Consent Form

Exclusion criteria

Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
Subjects with any implantable metal device in the treatment area
Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
Subjects who have any form of suspicious lesion on the treatment area
Subjects with history of keloid formations or hypertrophic scarring
Pregnant or lactating Subjects
Subjects with Epilepsy or severe migraines
Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
Subjects with any Infection / abscess / pains in treatment target area
Eczema or dermatitis
Subjects who suffer from autoimmune disorders or diabetes
Subjects using blood thinning medications
Subjects with clotting disorders
Subjects on drugs or psychologically determined unsuitable for the study
Subject is suffering extreme general weakness
Subject objects to the study protocol
Concurrent participation in any other clinical study
Physician objection