Lutronic Genius System for Neck Treatment

NCT03534609 | Completed FDA Device

• 1 other identifier: L18000
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle; Skin Laxity; Skin Texture Disorder

Outcome Measures

Primary Outcomes (1)

• Masked qualitative assessment of improvement

  An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors evaluating for improvement in neck appearance from pre- to post-treatment. The assessors choose the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.

  From baseline to 90 days following the last treatment

Secondary Outcomes (4)

• Clinician aesthetic improvement

  From baseline to Days 90 following the last study treatment.

• Subject aesthetic improvement

  From baseline to Days 90 following the last study treatment.

• Patient Satisfaction

  From baseline to 90 days following the last study treatment

• Treatment-related pain

  For the duration of each study treatment which typically can last up to approximately 90 minutes.

Study Arms (1)

Genius System Neck Treatment

EXPERIMENTAL

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

Device: Lutronic Genius System

Interventions

Lutronic Genius System DEVICE

Treatment of the neck using the Lutronic Genius System

Genius System Neck Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• 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.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if:

• 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.
• History of skin disorders, keloid scarring, and/or abnormal wound healing.
• Open wounds or lesions in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• History of chronic drug or alcohol abuse.
• History of vascular disease.
• History of bleeding disorders.
• BMI equal to or greater than 30.
• Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
• Subjects with current skin cancer or other malignant disease including pre-malignant moles.
• 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.
• Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers.
• Subjects with sensitivity or allergy to gold.
• Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (1)

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Kari Larson, MBA

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, open label

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 23, 2018
• Study Start: March 27, 2018
• Primary Completion: January 16, 2019
• Study Completion: January 10, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)