- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945685
Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening
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).
EndyMion has developed the Imagine™ 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 Imagine™ system.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Rishon Le Zion, Israel
- Elman Clinique
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Endymion study group
|
Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed):
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The safety of using the Imagine™ System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn).
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy endpoint of using the Imagine™ System for skin tightening will be established by level of skin tightness improvement.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Varda Godfried, Dr., Endymion Medical Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EN-IOP - 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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