Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture (Quantum001)

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Elasticity; Skin Laxity; Skin Firmness; Skin Tightening; Liposuction; Body Contouring Surgery
• Intervention / Treatment: Device: Quantum RF

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauricio Perez, MD; Email: meperezmd@gmail.com
• Study Contact Backup: Name: Alfredo Hoyos, Plastic Surgeon; Phone Number: +13059154274; Email: alhoyos@gmail.com

Study Locations

• Colombia
  • DC
    • Bogota, DC, Colombia
      • Recruiting
      • Dhara Clinic
      • Contact: Alfredo Hoyos, MD, Plastic Surgeon; Phone Number: +13059154274; Email: alhoyos@gmail.com
      • Principal Investigator: Alfredo Hoyos, MD, Plastic Surgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Quantum RF; Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of skin laxity, and improvement of the appearance. The GAIS is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions: how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change.; Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied.; Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.	6 months

Collaborators and Investigators

• Sponsor: Total Definer Research Group

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: April 27, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Liposuction; Body contouring; Liposculpture; High Definition Liposculpture; Quantum; Quantum RF; Elastometer
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: Quantum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Depending upon reasonable request
• IPD Sharing Time Frame: After results publication in scientific manuscript
• IPD Sharing Access Criteria: Request to the main author, stating the aims of the request, and the use the data will be given
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No