Lutronic Genius System for Neck Treatment

NCT ID: NCT03534609

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2020-01-10

Brief Summary

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.

Detailed Description

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.

Conditions

Wrinkle; Skin Laxity; Skin Texture Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genius System Neck Treatment

Lutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck.

Group Type: EXPERIMENTAL

Lutronic Genius System

Intervention Type: DEVICE

Treatment of the neck using the Lutronic Genius System

Interventions

Lutronic Genius System

Treatment of the neck using the Lutronic Genius System

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LUTRONIC Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Larson, MBA

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Laser and Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

L18000

Identifier Type: -

Identifier Source: org_study_id