Phase
Condition
N/ATreatment
Venus Bliss
Clinical Study ID
Ages 21-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who are currently seeking abdominoplasty surgery and are consenting totheir tissue that is being excised, to be tested
Informed consent agreement signed by the subject.
Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI,it is recommended to use the Matrix applicators on skin types I-V).
Willingness to follow the treatment and follow-up schedule and the post-treatmentcare.
For female candidates - post-menopausal or surgically sterilized, or using amedically acceptable form of birth control at least 3 months prior to enrollment andduring the entire course of the study (i.e., oral contraceptives, IUD, contraceptiveimplant, barrier methods with spermicide, or abstinence).
Exclusion
Exclusion Criteria:
Pregnant and/or breastfeeding.
Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex inthe treated area, unless treatment is conducted following a prophylactic regimen.
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containingagents) one week before and after the treatment session.
Use of retinoids, antioxidants or therapeutic skin nourishing supplements atmedicinal concentration within 2 months of treatment or during the study and oralretinoids within 6 months of the study.
Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
Having received collagen/fat injections or other methods of augmentation withinjected or implanted material in the treated area within 9 months of treatment orduring the study.
Having received Botox in the treated area within 6 months of treatment or during thestudy.
Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
History of keloid scarring or of abnormal wound healing.
Suffering from current or history of significant skin conditions in the treated areaor inflammatory skin conditions, including, but not limited to: active acne,excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe openwound stage), varicella scars, open lacerations or abrasions and active cold soresor herpes sores prior to treatment (duration of resolution as per the Investigator'sdiscretion) or during the treatment course.
History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) or currently using immunosuppressive medications.
History of epidermal or dermal disorders (particularly if involving collagen ormicrovascularity).
History of pigmentary disorders, particularly tendency for hyper- orhypo-pigmentation.
Suffering from hormonal imbalance, as per the Investigator's discretion.
Having a known anticoagulative or thromboembolic condition or taking anticoagulationmedications one week prior to and during the treatment course (to allow inclusion,temporary cessation of use as per the subject's physician discretion).
Having or undergoing any form of treatment for active cancer, or having a history ofskin cancer or any other cancer in the areas to be treated, including actinickeratosis, presence of malignant or pre-malignant pigmented lesions.
Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
Vascular lesion, tattoo or permanent make-up in the treated area.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanningduring the study.
Participation in a study of another device or drug within three month prior toenrollment or during the study.
As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study.
Study Design
Study Description
Connect with a study center
Dr. Brian Kinney Plastic Surgeon
Beverly Hills, California 90212
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
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