Lutronic Genius System for Neck Treatment



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:March 27, 2018
End Date:December 31, 2019
Contact:Kari Larson, MBA
Email:klarson@lutronic.com
Phone:801.244.0058

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Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck

The Genius system is substantially equivalent to the Infini device (K121481). The study is a
prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for
treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the
neck.

At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each
subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects
will be contacted via a phone call 3 days following each treatment to assess for adverse
events and expected treatment effects. Effectiveness assessments will occur prior to
Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment
#3. Each assessment visit will include efficacy, adverse events, and expected treatment
effects assessments, and post-treatment 2D and 3D digital images will be captured.

Inclusion Criteria:

1. Male or female, age 18 years and older.

2. Subject in good health.

3. Fitzpatrick Skin Type I to VI.

4. Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

5. Understands and accepts the obligation not to undergo any other procedures in the
areas to be treated through the follow-up period.

6. Willingness and ability to comply with protocol requirements, including returning for
follow-up visits and abstaining from exclusionary procedures for the duration of the
study.

7. Post-menopausal, surgically sterilized, or using a medically acceptable form of birth
control at least 3 months prior to enrollment and during the entire course of the
study.

8. Absence of physical or psychological conditions unacceptable to the investigator.

9. Willingness and ability to provide written consent for study-required photography and
adherence to photography procedures (i.e., removal of jewelry and makeup).

10. Willingness and ability to provide written informed consent and HIPAA authorization
prior to performance of any study-related procedure.

Exclusion Criteria:

1. Presence of an active skin condition or infection in the treatment area such as sores,
Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex
breakout.

2. History of skin disorders, keloid scarring, and/or abnormal wound healing.

3. Open wounds or lesions in the area(s) to be treated.

4. Inability to understand the protocol or to give informed consent.

5. History of chronic drug or alcohol abuse.

6. History of vascular disease.

7. History of bleeding disorders.

8. BMI equal to or greater than 30.

9. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the
trial.

10. Subjects with current skin cancer or other malignant disease including pre-malignant
moles.

11. Poorly controlled medical condition that could compromise wound healing or increase
risk of infection such as an impaired immune system due to immunosuppressive diseases
such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or
chemotherapy.

12. Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal
within the treatment area, and other implantable devices or synthetic fillers.

13. Subjects with sensitivity or allergy to gold.

14. Subjects with sensitivity or allergy to local anesthetics such as lidocaine or
tetracaine.

15. Concurrent enrollment in any study involving the use of investigational devices or
drugs.

16. History of surgical or cosmetic treatments in the area(s) to be treated within the
past six months.

17. History or current use of the following prescription medications:

1. Daily anticoagulants, aspirin, iron supplements, herbal supplements such as
ginkgo, ginseng or garlic within the past two weeks;

2. Topical retinoid within the past one week; and

3. Psychiatric drugs that in the investigators opinion would impair the subject from
understanding the protocol requirements or understanding and signing the informed
consent.
We found this trial at
1
site
New York, New York 10016
Principal Investigator: Roy Geronemus, MD
Phone: 212-686-7306
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mi
from
New York, NY
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