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

NCT06958978 | Recruiting

• 1 other identifier: Quantum
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Quantum; Quantum RF; Elastometer; Body contouring; Liposuction; Liposculpture; High Definition Liposculpture

Outcome Measures

Primary Outcomes (3)

• Skin elasticity

  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.

  6 months

• Skin Viscoelasticity

  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

  6 months

• Skin retraction time

  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

  6 months

Secondary Outcomes (1)

• Patient satisfaction

  6 months

Study Arms (1)

Quantum RF

EXPERIMENTAL

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.

Device: Quantum RF

Interventions

Quantum RF DEVICE

Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.

Quantum RF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (1)

Dhara clinic

Bogotá, DC, Colombia

RECRUITING

Related Publications (3)

• Ibrahiem SMS. Aesthetic Nonexcisional Arm Contouring. Aesthet Surg J. 2022 Jun 20;42(7):NP463-NP473. doi: 10.1093/asj/sjac031.

  PMID: 35170726 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Alfredo Hoyos, Plastic Surgeon

CONTACT

+13059154274; alhoyos@gmail.com

Mauricio Perez, MD

CONTACT

meperezmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: All patients will receive Quantum Radiofrequency device as intervention in the anatomical areas were the skin laxity requires treatment. The skin laxity variables will be collected for all the areas at baseline (after liposculpture), immediate after Quantum, and during follow up months 1, 3, and 6.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: May 6, 2025
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After results publication in scientific manuscript
• Access Criteria: Request to the main author, stating the aims of the request, and the use the data will be given

Locations

CO (1)