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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTotal Definer Research Group

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Quantum RF

    Device

    Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Quantum RFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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

Time frame
6 months
3

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

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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