Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
Total Definer Research Group
80 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
Summary
This prospective study aims to evaluate the safety and effectiveness of Quantum, a fully internal bipolar radiofrequency probe, for the treatment of prominent skin laxity, providing patients with a more toned and youthful appearance, in patients undergoing High-Definition (HD) Liposculpture. The main questions this study seeks to answer are: * Does Quantum reduce skin laxity in patients undergoing HD Liposculpture? * Is the effectiveness in skin laxity reduction influenced by demographical factors, including age, gender, and phototype? The participants will be adult patients (between 18-60 years) undergoing HD Liposculpture, with any measurable degree of skin laxity. The participants can not be pregnant, have history of scaring/healing problems, autoimmune diseases, severe dermatological conditions, have metal implants, be obese, or have important comorbidities.
Eligibility
Inclusion Criteria2
- Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy.
- Healthy patients without underlying comorbidities (classified as ASA≤II)
Exclusion Criteria5
- Pregnant patients, patients planning to get pregnant, or in breastfeeding stage
- Past medical history of any collagen disease or autoimmune conditions, including lupus, scleroderma, connective tissue disorders, rheumatoid arthritis, or multiple sclerosis.
- Past medical history of skin disease including active skin infections, dermatitis, or history of keloid formation.
- Patient with any metal implants or pacemakers
- BMI ≥ 32 kg/m2.
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Interventions
Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.
Locations(1)
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NCT06958978