Skin LaxityQuantum001NCT06958978
Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
A study testing Quantum RF in people with Skin Laxity and Skin Tightening, run by Total Definer Research Group at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Skin Tightening, Body Contouring Surgery
- What is being tested?
- Quantum RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mauricio Perez, MD contact
Colombia1 site, 1 recruiting
- Recruiting
Dhara clinic
Bogotá, DC
Alfredo Hoyos, MD, Plastic Surgeon, +13059154274, alhoyos@gmail.com
Alfredo Hoyos, MD, Plastic Surgeon
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Skin Laxity, Skin Tightening, Body Contouring Surgery, Skin Elasticity, Skin Firmness, Liposuction
- Being tested
- Quantum RF
- Keywords
- Quantum, Quantum RF, Elastometer, Body contouring, Liposuction, Liposculpture, High Definition Liposculpture
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum RFDevice
Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Quantum RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Total Definer Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Hoyos, Total Definer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958978
- Sponsor's protocol ID
- Quantum
- Acronym
- Quantum001
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depending upon reasonable request
Publications
Ibrahiem SMS. Aesthetic Nonexcisional Arm Contouring. Aesthet Surg J. 2022 Jun 20;42(7):NP463-NP473. doi: 10.1093/asj/sjac031.
PubMed 35170726Chia 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.
PubMed 26301148Cala 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.
PubMed 38948160
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
- ClinicalTrials.gov ID
- NCT06958978
- Acronym / sponsor ID
- Quantum001 / Quantum
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Total Definer Research GroupUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quantum RF | Experimental | Device: Quantum RFRight 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantum RFPatented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment. | Device | Quantum RF |
Primary outcome
Skin elasticity
Time frame: 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
Time frame: 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
Skin retraction time
Time frame: 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
1 secondary outcome
Patient satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 35170726Ibrahiem SMS. Aesthetic Nonexcisional Arm Contouring. Aesthet Surg J. 2022 Jun 20;42(7):NP463-NP473. doi: 10.1093/asj/sjac031.
- Background: PubMed 26301148Chia 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.
- Background: PubMed 38948160Cala 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.
- Individual participant dataSharing planned: Yes. Depending upon reasonable request
Related trials for Skin Laxity
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Active, not recruiting
Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity
Laxity; Skin
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauricio Perez, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantum RF in people with Skin Laxity and Skin Tightening, run by Total Definer Research Group at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfredo Hoyos, Plastic Surgeon (+13059154274, alhoyos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin elasticity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.