Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Skin retraction time
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Quantum RF
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.
干预措施: Quantum RF (Device)
结局指标
主要结局
Skin retraction time
时间窗: 6 months
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
Skin elasticity
时间窗: 6 months
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
时间窗: 6 months
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
次要结局
- Patient satisfaction(6 months)
研究者
Alfredo Hoyos
Plastic Surgeon
Total Definer Research Group