Evaluation of Efficacy and Safety of the triLift™ System

NCT ID: NCT05773924

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2023-08-15

Brief Summary

Single center, single-arm, prospective, open Label with Before & After Study Design.

Detailed Description

Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.

Conditions

Skin Laxity; Wrinkle

Study Design

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

Study Groups

Trilift system treatment arm

Single arm with Before \& After photos, triLift treatment protocol study design.

Group Type: OTHER

triLift system

Intervention Type: DEVICE

To evaluate the efficacy of the triLift™ treatment

Interventions

triLift system

To evaluate the efficacy of the triLift™ treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is willing and able to read, understand, and sign the informed consent.
• Healthy male or female aged 35 - 55 years.
• Fitzpatrick skin type 1-6.
• Subject is capable of reading, understanding, and following instructions of the procedure to be applied.
• Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.

Exclusion Criteria

• Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
• Concurrent participation in any other study.
• Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
• Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
• Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
• Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
• Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study.
• Subject has used topical retinoids in the past 1 month.
• History of systemic cancer; premalignant skin lesion or skin concern treatment area.
• Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
• Poorly controlled endocrine disorders such as diabetes.
• Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
• History of collagen disorders, keloid formation or abnormal wound healing.
• Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing.
• Subject has used oral steroids in the past 6 months.
• Subject has used topical steroids in the past 3 months.
• History of bleeding coagulopathies or use of anticoagulants.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment.
• Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.)
• Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements.
• Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle Kauvar, MD

Role: PRINCIPAL_INVESTIGATOR

New York Laser & Skin Care

Locations

NY Laser Skin Care

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fiona Kerr

Role: CONTACT

nurses@nylaserskincare.com

212-249-9440

Facility Contacts

Arielle Kauvar, MD

Role: primary

info@nyskincare.com

212-249-9440

Other Identifiers

LUM-ABU-triLift-22-01

Identifier Type: -

Identifier Source: org_study_id