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

NCT01029301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-12-09

No results posted yet for this study

Summary

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.

Conditions

  • Skin Aging
  • Skin Wrinkling

Interventions

DEVICE

Device: EndyMed Pro System for Skin Tightening

Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening);

Sponsors & Collaborators

  • Endymion Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Varda Godfried, Dr. · EndyMed Medical Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

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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 NCT01029301 on ClinicalTrials.gov