About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Quantum RF
DevicePatented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.
Treatment groups
Trial outcomes
Primary outcomes
Skin elasticity
Objectively calculate using Elastometer the difference in the skin elasticity measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on the 1st, 3rd and 6th month.
Skin Viscoelasticity
Objectively calculate using Elastometer the difference in the skin viscoelasticity measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on 1st, 3rd and 6th month
Skin retraction time
Objectively calculate using Elastometer the difference in the retraction time measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on 1st, 3rd and 6th month
Secondary outcomes
Patient satisfaction
Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of skin laxity, and improvement of the appearance. The GAIS is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions: * how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change. * Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied. * Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.
Sponsors and contacts
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