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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Quantum RF
  Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.

Первичные конечные точки

• Skin elasticity [Срок оценки: 6 months]
• Skin Viscoelasticity [Срок оценки: 6 months]
• Skin retraction time [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Patient satisfaction [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• Dhara clinic — Bogotá

Публикации

• Ibrahiem SMS. Aesthetic Nonexcisional Arm Contouring. Aesthet Surg J. 2022 Jun 20;42(7):NP463-NP473. doi: 10.1093/asj/sjac031. PMID 35170726
• Chia CT, Theodorou SJ, Hoyos AE, Pitman GH. Radiofrequency-Assisted Liposuction Compared with Aggressive Superficial, Subdermal Liposuction of the Arms: A Bilateral Quantitative Comparison. Plast Reconstr Surg Glob Open. 2015 Aug 10;3(7):e459. doi: 10.1097/GOX.0000000000000429. eCollection 2015 Jul. PMID 26301148
• Cala Uribe LC, Perez Pachon ME, Babaitis R, Zannin Ferrero A, Aljure Diaz MF. Variable Energy and Ultrasound-based Liposculpture of the Arms: Multicenter and Multidevice Study. Plast Reconstr Surg Glob Open. 2024 Mar 19;12(3):e5649. doi: 10.1097/GOX.0000000000005649. eCollection 2024 Mar. PMID 38948160

Идентификаторы

NCT: NCT06958978 · Quantum

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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