Evaluation of Efficacy and Safety of the triLift™ System
Single center, single-arm, prospective, open Label with Before \& After Study Design.
Conditions:
🦠 Skin Laxity 🦠 Wrinkle
🗓️ Study Start (Actual) 10 February 2023
🗓️ Primary Completion (Estimated) 15 August 2023
✅ Study Completion (Estimated) 15 August 2023
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 35 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 February 2023
  • First Submitted that Met QC Criteria 6 March 2023
  • First Posted 17 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 March 2023
  • Last Update Posted 17 March 2023
  • Last Verified February 2023