Status:
RECRUITING
Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
Lead Sponsor:
Total Definer Research Group
Conditions:
Skin Laxity
Skin Tightening
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 mo...
Detailed 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 particip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06958978
Start Date
February 1 2024
End Date
June 1 2026
Last Update
May 6 2025
Active Locations (1)
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1
Dhara clinic
Bogotá, DC, Colombia