Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture (Quantum001)

Total Definer Research Group

Status: Enrolling

Conditions: Skin Elasticity; Liposuction; Skin Tightening; Skin Firmness; Body Contouring Surgery; Skin Laxity

Treatments: Device: Quantum RF

Study type: Interventional

Funder types: Other

Identifiers

NCT06958978

Quantum

Details and patient eligibility

About

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.

Full description

Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.

Eligible patients will be approached, the study aims, objectives, procedures, and voluntary participation will be explained. In case patient consent to participate, a written informed consent will be signed. The patients will be comprehensively evaluated by the plastic surgeon, and the areas selected for Quantum use, will be chosen according to the degree of skin laxity of the anatomical region.

Data Collection:

• Demographic, Clinical, and surgical variables are going to be collected in an Excel-based password protected database.
• Other procedure related variables are also going to be collected in the same database, hemoglobin and hematocrit levels, time to discharge, and complications.
• The effect of the intervention in the skin laxity will be measured with Elastometer after liposculpture before Quantum, right after Quantum use, 1, 3 and 6 months post procedure. Variables to collect will include area, skin thickness, elasticity, viscoelasticity, and time to retraction.
• Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.
• Photographical records will be kept with images pre procedure, and at follow up 1, 3, and 6 months.

The study procedures include:

• Procedure: All patients will undergo the standardized HD Liposculpture technique. Measurements of skin laxity will be performed with the Elastometer. Using the same ports of Liposculpture, Quantum device will be inserted, and the radiofrequency energy used in recommended parameters (energy 15 J, pulse mode 3.0 pps). Once the procedure is finished, with the patient still in operating table take the first post-treatment skin laxity measurements.
• Post procedure follow up: Skin laxity measurements with Elastometer in 1, 3, and 6 months postoperative controls.

Study Locations: Dhara Clinic (Bogota, Colombia)

Ethical Considerations:

• IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB).
• Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained.
• Data Confidentiality: All participant data will be anonymized and securely stored.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Quantum RF

Experimental group

Description:

Right after the Liposuction procedure is completed, introduce the Quantum RF probe through the incision ports used for the liposuction. Using an imaginary grid with 1x1 cm pattern, apply assuring even distribution the Quantum RF (energy 15 J, pulse mode 3.0 pps) in the anatomical area. Maintain a uniform pace and energy level across the grid, covering both superficial and deep layers, to avoid hotspots and ensure consistent results.

Treatment:

Device: Quantum RF