Lipid Metabolism DisordersNCT04819321
Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
A study testing CoolSculpting® System in people with Lipid Metabolism Disorders and Metabolic Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders, Metabolic Disease
- What is being tested?
- CoolSculpting® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
- Subject has a BMI of 24.9 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
- Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
- Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Who cannot join
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
- Subject is pregnant or intending to become pregnant. Subject is lactating or has been lactating in the past 6-9 months. Subject is unable or unwilling to comply with study requirements. Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
- Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Show all 15Show fewer
- Subject with known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin such as cold urticaria or Raynaud's disease, or Chilblains (pernio).
- Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
- Subject with impaired peripheral circulation in the area to be treated Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
- Subject with impaired skin sensation. Subject with open or infected wounds. Subject with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject with recent surgery or scar tissue in the area to be treated. Subject has history of hernia in or adjacent to the treatment area(s) site. Subject with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject is taking or has taken diet pills or supplements within the past 6 months.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
- Subject diagnosed with fibrosis.
Trial locations and contacts
1 site in 1 country.
Mariele L Silva, Master contact
Brazil1 site
Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.
Read the detailed description
This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Federal University of Minas Gerais (UFMG). The project will be submitted for evaluation by the Research Ethics Committee (COEP / UFMG). All participants must sign the informed consent form (ICF), before the study begins.
The experimental design will consist of five stages. Initially, women will be public recruitment. Through telephone contact, the inclusion and exclusion criteria will be verified, and volunteers who meet the criteria will be invited to attend the clinic for the first stage of the study. The presentation of the research, will be carried out 7 days before the beginning of the treatment, will consist of presenting the project to the volunteers, explaining all the risks and benefits related to the study and request the signature of the ICF. After 7 days, the volunteers must return to the clinic, then start the study. In the initial evaluation, an anamnesis of the volunteers will be carried out with a standardized form, including socioeconomic and clinical data, data on the use of medications, alcohol consumption, physical activity and food consumption. In addition, anthropometric assessments will be performed where weight, height, waist, abdominal and hip circumference will be measured. Ultrasonography will also be performed; the abdominal region will be photographed and blood will be collected to measure lipolytic and inflammatory markers and a biopsy of the subcutaneous WAT in the lower abdomen via umbilical scar. In addition, questionnaires will be applied to check the volunteers' satisfaction with the treatment. After 30 days, the volunteers must return to the clinic for time 0 (T0), where anthropometric assessments will be repeated as control variables. Ultrasound and blood collection will also be performed. Then the volunteers will be submitted to cryolipolysis in the abdominal region by the Coolsculpting® system. After 3 days of performing the Coolsculpting® procedure, the volunteers must return to the clinic for time 3 (T3), to perform a new biopsy of the subcutaneous WAT in the lower abdomen via the umbilical scar. After 60 days of the cryolipolysis, the volunteers must return to the clinic for the time 60 (T60), where all the evaluations of the initial evaluation will be carried out again and a personal satisfaction questionnaire will be applied in relation to the result of the procedure. Therefore, the study will total 97 days of monitoring of women, who will be instructed to maintain healthy lifestyle habits, according to the conventional lifestyle of each one of them. The data, images and biological materials (blood and adipose tissue biopsy) collected in the research will be filed with the researcher responsible for a period of 5 (five) years at the Experimental Nutrition Laboratory, room 315, of the UFMG School of Nursing and after that time will be destroyed. In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out.
- Conditions
- Lipid Metabolism Disorders, Metabolic Disease
- Being tested
- CoolSculpting® System
- Keywords
- CoolSculpting, adipose tissue, cryolipolysis, browning
- Medical subject headings
- Lipid Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSculpting® SystemDevice
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
| Study group | Role | What they receive |
|---|---|---|
| CoolSculpting® System | Experimental | A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage Receives: Device: CoolSculpting® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue biology
Fat cell death after cooling by cryolipolysis
Measured: 3 days after the procedure
Change in volume of fat from baseline
To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.
Measured: 60 days after the procedure
Secondary outcomes (2)
Decrease in abdominal circumference
decreased abdominal circumference after death of adipocytes
Measured: 60 days after the procedure
Browning of white adipose tissue
browning of white adipose tissue
Measured: 3 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI\> 24.9 kg / m² and \<30.0 kg / m²).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Principal investigator, Adaliene Versiani M. Ferreira, Federal University of Minas Gerais
- Investigators
- Mariele L Silva, Master, Study chair, Federal University of Minas GeraisAmanda CC Oliveira, Master, Study chair, Federal University of Minas GeraisAdma M Babetto, Student, Study chair, Federal University of Minas GeraisAdaliene VM Ferreira, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819321
- Sponsor's protocol ID
- 30339520.8.0000.5149
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Agrawal M, Kern PA, Nikolajczyk BS. The Immune System in Obesity: Developing Paradigms Amidst Inconvenient Truths. Curr Diab Rep. 2017 Aug 15;17(10):87. doi: 10.1007/s11892-017-0917-9.
PubMed 28812211Aldiss P, Betts J, Sale C, Pope M, Budge H, Symonds ME. Exercise-induced 'browning' of adipose tissues. Metabolism. 2018 Apr;81:63-70. doi: 10.1016/j.metabol.2017.11.009. Epub 2017 Nov 16.
PubMed 29155135Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864.
PubMed 20014262Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3.
PubMed 24535759Harms M, Seale P. Brown and beige fat: development, function and therapeutic potential. Nat Med. 2013 Oct;19(10):1252-63. doi: 10.1038/nm.3361. Epub 2013 Sep 29.
PubMed 24100998Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki GH. Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms. Plast Reconstr Surg. 2015 Jun;135(6):1581-1590. doi: 10.1097/PRS.0000000000001236.
PubMed 26017594Kajimura S, Spiegelman BM, Seale P. Brown and Beige Fat: Physiological Roles beyond Heat Generation. Cell Metab. 2015 Oct 6;22(4):546-59. doi: 10.1016/j.cmet.2015.09.007.
PubMed 26445512Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
PubMed 27327898Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. Lasers Surg Med. 2016 Jan;48(1):3-13. doi: 10.1002/lsm.22440. Epub 2015 Nov 26.
PubMed 26607045Krueger N, Mai SV, Luebberding S, Sadick NS. Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol. 2014 Jun 26;7:201-5. doi: 10.2147/CCID.S44371. eCollection 2014.
PubMed 25061326Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.
PubMed 24954193Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008 Nov;40(9):595-604. doi: 10.1002/lsm.20719.
PubMed 18951424Nelson AA, Wasserman D, Avram MM. Cryolipolysis for reduction of excess adipose tissue. Semin Cutan Med Surg. 2009 Dec;28(4):244-9. doi: 10.1016/j.sder.2009.11.004.
PubMed 20123423Shek SY, Chan NP, Chan HH. Non-invasive cryolipolysis for body contouring in Chinese--a first commercial experience. Lasers Surg Med. 2012 Feb;44(2):125-30. doi: 10.1002/lsm.21145.
PubMed 22334296Leal Silva H, Carmona Hernandez E, Grijalva Vazquez M, Leal Delgado S, Perez Blanco A. Noninvasive submental fat reduction using colder cryolipolysis. J Cosmet Dermatol. 2017 Dec;16(4):460-465. doi: 10.1111/jocd.12383. Epub 2017 Sep 12.
PubMed 28901051
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
- ClinicalTrials.gov ID
- NCT04819321
- Acronym / sponsor ID
- 30339520.8.0000.5149
- Conditions
- Lipid Metabolism Disorders, Metabolic Disease
- Keywords
- CoolSculpting, adipose tissue, cryolipolysis, browning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Allergan Sales, LLC
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 26 Mar 2021 (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.
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.
Detailed description
This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Federal University of Minas Gerais (UFMG). The project will be submitted for evaluation by the Research Ethics Committee (COEP / UFMG). All participants must sign the informed consent form (ICF), before the study begins.
The experimental design will consist of five stages. Initially, women will be public recruitment. Through telephone contact, the inclusion and exclusion criteria will be verified, and volunteers who meet the criteria will be invited to attend the clinic for the first stage of the study. The presentation of the research, will be carried out 7 days before the beginning of the treatment, will consist of presenting the project to the volunteers, explaining all the risks and benefits related to the study and request the signature of the ICF. After 7 days, the volunteers must return to the clinic, then start the study. In the initial evaluation, an anamnesis of the volunteers will be carried out with a standardized form, including socioeconomic and clinical data, data on the use of medications, alcohol consumption, physical activity and food consumption. In addition, anthropometric assessments will be performed where weight, height, waist, abdominal and hip circumference will be measured. Ultrasonography will also be performed; the abdominal region will be photographed and blood will be collected to measure lipolytic and inflammatory markers and a biopsy of the subcutaneous WAT in the lower abdomen via umbilical scar. In addition, questionnaires will be applied to check the volunteers' satisfaction with the treatment. After 30 days, the volunteers must return to the clinic for time 0 (T0), where anthropometric assessments will be repeated as control variables. Ultrasound and blood collection will also be performed. Then the volunteers will be submitted to cryolipolysis in the abdominal region by the Coolsculpting® system. After 3 days of performing the Coolsculpting® procedure, the volunteers must return to the clinic for time 3 (T3), to perform a new biopsy of the subcutaneous WAT in the lower abdomen via the umbilical scar. After 60 days of the cryolipolysis, the volunteers must return to the clinic for the time 60 (T60), where all the evaluations of the initial evaluation will be carried out again and a personal satisfaction questionnaire will be applied in relation to the result of the procedure. Therefore, the study will total 97 days of monitoring of women, who will be instructed to maintain healthy lifestyle habits, according to the conventional lifestyle of each one of them. The data, images and biological materials (blood and adipose tissue biopsy) collected in the research will be filed with the researcher responsible for a period of 5 (five) years at the Experimental Nutrition Laboratory, room 315, of the UFMG School of Nursing and after that time will be destroyed. In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²).
| Arm | Type | Receives |
|---|---|---|
| CoolSculpting® System | Experimental | Device: CoolSculpting® SystemA treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
- Subject has a BMI of 24.9 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
- Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
- Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Key exclusion criteria (15 listed)
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
- Subject is pregnant or intending to become pregnant. Subject is lactating or has been lactating in the past 6-9 months. Subject is unable or unwilling to comply with study requirements. Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
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 |
|---|---|---|
| CoolSculpting® SystemA treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage | Device | CoolSculpting® System |
Primary outcome
Adipose tissue biology
Time frame: 3 days after the procedure
Fat cell death after cooling by cryolipolysis
Change in volume of fat from baseline
Time frame: 60 days after the procedure
To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.
2 secondary outcomes
Decrease in abdominal circumference
Time frame: 60 days after the procedure
Browning of white adipose tissue
Time frame: 3 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 28812211Agrawal M, Kern PA, Nikolajczyk BS. The Immune System in Obesity: Developing Paradigms Amidst Inconvenient Truths. Curr Diab Rep. 2017 Aug 15;17(10):87. doi: 10.1007/s11892-017-0917-9.
- Background: PubMed 29155135Aldiss P, Betts J, Sale C, Pope M, Budge H, Symonds ME. Exercise-induced 'browning' of adipose tissues. Metabolism. 2018 Apr;81:63-70. doi: 10.1016/j.metabol.2017.11.009. Epub 2017 Nov 16.
- Background: PubMed 20014262Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864.
- Background: PubMed 24535759Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3.
- Background: PubMed 24100998Harms M, Seale P. Brown and beige fat: development, function and therapeutic potential. Nat Med. 2013 Oct;19(10):1252-63. doi: 10.1038/nm.3361. Epub 2013 Sep 29.
- Background: PubMed 26017594Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki GH. Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms. Plast Reconstr Surg. 2015 Jun;135(6):1581-1590. doi: 10.1097/PRS.0000000000001236.
- Background: PubMed 26445512Kajimura S, Spiegelman BM, Seale P. Brown and Beige Fat: Physiological Roles beyond Heat Generation. Cell Metab. 2015 Oct 6;22(4):546-59. doi: 10.1016/j.cmet.2015.09.007.
- Background: PubMed 27327898Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
- Background: PubMed 26607045Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. Lasers Surg Med. 2016 Jan;48(1):3-13. doi: 10.1002/lsm.22440. Epub 2015 Nov 26.
- Background: PubMed 25061326Krueger N, Mai SV, Luebberding S, Sadick NS. Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol. 2014 Jun 26;7:201-5. doi: 10.2147/CCID.S44371. eCollection 2014.
- Background: PubMed 24954193Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.
- Background: PubMed 18951424Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008 Nov;40(9):595-604. doi: 10.1002/lsm.20719.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mariele L Silva, Master contact
Mariele L Silva, Master study chair
Federal University of Minas Gerais
Amanda CC Oliveira, Master study chair
Federal University of Minas Gerais
Adma M Babetto, Student study chair
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolSculpting® System in people with Lipid Metabolism Disorders and Metabolic Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adaliene VM Ferreira, PhD (+553134093680, adaliene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue biology (time frame: 3 days after the procedure). The study lists 2 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 NCT04819321, which also lists 18 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 26 Mar 2021.