Aesthetic Nonexcisional Arm Contouring.
Saad Mohamed Saad Ibrahiem
https://pubmed.ncbi.nlm.nih.gov/35170726Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06958978
Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
Led by Total Definer Research Group · Updated on 2025-05-06
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Quantum, a fully internal bipolar radiofrequency probe, to study its safety and effectiveness in reducing prominent skin laxity among adult patients undergoing High-Definition (HD) Liposculpture. This prospective interventional study also explores whether factors like age, gender, and skin phototype affect the treatment's success in making skin appear more toned and youthful. In this study, all participants will undergo standardized HD Liposculpture followed by the use of the Quantum device. The device is inserted through the same incisions used during liposculpture and delivers radiofrequency energy in a controlled grid pattern across the treated area. Energy is applied at specific settings (15 J, pulse mode 3.0 pps) to evenly treat both superficial and deep skin layers. Follow-up periods include immediate post-treatment and assessments at 1, 3, and 6 months after the procedure. Participants will be evaluated before and after treatment using an Elastometer to measure skin elasticity, viscoelasticity, and time to skin retraction. Data on demographics, clinical variables, surgical parameters, blood markers, complications, and patient satisfaction (via the Global Aesthetic Improvement Scale) will be collected securely. Photographs will document changes at baseline and during follow-ups up to 6 months. The study involves a total participation duration of 6 months with ongoing safety and effectiveness monitoring.
CONDITIONS
Brief Title
Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients undergoing body contouring procedures such as liposuction or liposculpture, alone or combined with up to two major aesthetic procedures involving face, breast, or dermolipectomy
- Healthy patients without significant underlying health issues (ASA class II or lower)
You will not qualify if you...
- Pregnant individuals, those planning pregnancy, or breastfeeding
- History of collagen diseases or autoimmune conditions like lupus, scleroderma, connective tissue disorders, rheumatoid arthritis, or multiple sclerosis
- History of skin diseases including active infections, dermatitis, or keloid formation
- Presence of metal implants or pacemakers
- Body mass index (BMI) of 32 kg/m2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day procedure
Participants undergo high-definition liposculpture followed by the Quantum RF device application for skin rejuvenation and subdermal tightening during the same procedure.
1 procedure visit (in-person)
Follow-up
Duration - 6 months
Participants have skin laxity measurements and photographic records taken to assess the effects of the treatment.
Visits at 1 month, 3 months, and 6 months post-procedure (3 visits in-person)
Trial Site Locations
Total: 1 location
1
Dhara clinic
Bogotá, DC, Colombia
Actively Recruiting
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Research Team
A
Alfredo Hoyos, Plastic Surgeon
M
Mauricio Perez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Radiofrequency-Assisted Liposuction Compared with Aggressive Superficial, Subdermal Liposuction of the Arms: A Bilateral Quantitative Comparison.
Christopher T Chia, Spero J Theodorou, Alfredo E Hoyos...
https://pubmed.ncbi.nlm.nih.gov/26301148Variable Energy and Ultrasound-based Liposculpture of the Arms: Multicenter and Multidevice Study.
Laura C Cala Uribe, Mauricio E Perez Pachon, Ricardo Babaitis...
https://pubmed.ncbi.nlm.nih.gov/38948160