Evaluation of Efficacy and Safety of the triLift™ System (NCT05773924) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Efficacy and Safety of the triLift™ System
United States25 participantsStarted 2023-02-10
Plain-language summary
Single center, single-arm, prospective, open Label with Before \& After Study Design.
Who can participate
Age range35 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …