AgingNCT02368626
Safety and Efficacy of the EndyMed Pro System Using RF Micro-needles Fractional Skin Remodeling
A study testing EndyMed Pro™ RF Micro-Needles in people with Aging, run by EndyMed.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- EndyMed Pro™ RF Micro-Needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients age 35-60 with facial condition as required by the treatment.
- Subjects with Fitzpatrick elasticity level of 4 and above
- Subject able to comprehend and sign informed consent for participation in this study.
- Subject must commit to all treatments and follow-up visits.
- Subjects must approve the use of their B\&A photos by the doctor and EndyMed
Who cannot join
- Subjects with implanted pacemakers, arrhythmias or any other electronic implanted device or 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 3 months.
- Subjects that have had any other invasive or noninvasive method of skin therapy hair removal, filers or Botox, performed in the past 3 months (in the treated area).
- Subjects who are scheduled or planned for any other invasive or noninvasive method of skin therapy in the treatment area at the period of the study.
- Subjects who have any form of suspicious lesion on the treatment area.
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- Subjects with hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin.
- 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.
- History of any kind of cancer
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
- Any surgical procedure in the treatment area within the last 3 months or before complete healing.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- Treating over the thyroid, breast or any other sensitive area.
- 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 or unwilling to sign a consent form. Concurrent participation in any other clinical study.
- Any other condition that exclude the patient from the evaluation according to the physician judgment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Safety and Efficacy of the EndyMed Pro™ System Using Radiofrequency (RF) Micro-needles Fractional Skin Remodeling Handpiece (Intensif) for Wrinkle Reduction and Lifting - a Post Marketing Study
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
- Being tested
- EndyMed Pro™ RF Micro-Needles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndyMed Pro™ RF Micro-NeedlesDevice
RF Micro-needles ablation treatments
| Study group | Role | What they receive |
|---|---|---|
| RF ablation treatment | Experimental | 'EndyMed Pro™ RF Micro-Needles' - RF ablation treatments for wrinkle appearance reduction Receives: Device: EndyMed Pro™ RF Micro-Needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by Adverse events occurrence
Adverse events occurrence
Measured: 5 months
Secondary outcomes (1)
To evaluate the efficacy of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by wrinkle appearance reduction
wrinkle appearance reduction
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndyMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Gold, Dr, Principal investigator, Tennessee Clinical Research Center, Nashville, Tennessee, USAMark Taylor, Dr, Principal investigator, Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah, USAKenneth Rothaus, Dr, Principal investigator, Ageless Plastic Surgery, New York, NY, USAYohei Tanaka, Dr, Principal investigator, Clinica Tanaka Plastic and Reconstructive Surgery and Anti-aging Center, Tokyo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368626
- Sponsor's protocol ID
- EM-FR-01
- Status last verified
- Feb 2015
- First submitted
- 15 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the EndyMed Pro™ System Using Radiofrequency (RF) Micro-needles Fractional Skin Remodeling Handpiece (Intensif) for Wrinkle Reduction and Lifting - a Post Marketing Study
- ClinicalTrials.gov ID
- NCT02368626
- Acronym / sponsor ID
- EM-FR-01
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- EndyMedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF ablation treatment | Experimental | Device: EndyMed Pro™ RF Micro-Needles'EndyMed Pro™ RF Micro-Needles' - RF ablation treatments for wrinkle appearance reduction |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy patients age 35-60 with facial condition as required by the treatment.
- Subjects with Fitzpatrick elasticity level of 4 and above
- Subject able to comprehend and sign informed consent for participation in this study.
- Subject must commit to all treatments and follow-up visits.
- Subjects must approve the use of their B\&A photos by the doctor and EndyMed
Key exclusion criteria (25 listed)
- Subjects with implanted pacemakers, arrhythmias or any other electronic implanted device or 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 3 months.
- Subjects that have had any other invasive or noninvasive method of skin therapy hair removal, filers or Botox, performed in the past 3 months (in the treated area).
- Subjects who are scheduled or planned for any other invasive or noninvasive method of skin therapy in the treatment area at the period of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndyMed Pro™ RF Micro-NeedlesRF Micro-needles ablation treatments | Device | RF ablation treatment |
Primary outcome
To evaluate the safety of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by Adverse events occurrence
Time frame: 5 months
Adverse events occurrence
1 secondary outcome
To evaluate the efficacy of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by wrinkle appearance reduction
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gold, Dr principal investigator
Tennessee Clinical Research Center, Nashville, Tennessee, USA
Mark Taylor, Dr principal investigator
Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah, USA
Kenneth Rothaus, Dr principal investigator
Ageless Plastic Surgery, New York, NY, USA
Questions about this trial
What is this clinical trial studying?
A study testing EndyMed Pro™ RF Micro-Needles in people with Aging, run by EndyMed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr (+972-52-2824966, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by Adverse events occurrence (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.