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Safety and Efficacy of the EndyMed Pro System Using RF Micro-needles Fractional Skin Remodeling

NCT02368626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-02-23

No results posted yet for this study

Summary

The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling. System using focused ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting effect.8 Similar to these devices the EndyMed Pro™ System with RF Micro-Needles handpiece (INTENSIF) enables fractional skin coagulation with dermal heating for the reduction of wrinkles together with a lifting effect.

Conditions

  • Aging

Interventions

DEVICE

EndyMed Pro™ RF Micro-Needles

RF Micro-needles ablation treatments

Sponsors & Collaborators

  • EndyMed

    lead INDUSTRY

Principal Investigators

  • Michael Gold, Dr · Tennessee Clinical Research Center, Nashville, Tennessee, USA

  • Mark Taylor, Dr · Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah, USA

  • Kenneth Rothaus, Dr · Ageless Plastic Surgery, New York, NY, USA

  • Yohei Tanaka, Dr · Clinica Tanaka Plastic and Reconstructive Surgery and Anti-aging Center, Tokyo, Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368626 on ClinicalTrials.gov