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Recruiting NCT06958978

Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture

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Trial Parameters

Condition Skin Laxity
Sponsor Total Definer Research Group
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2024-02-01
Completion 2025-12
Interventions
Quantum RF

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Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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