AzTrials
AzTrials

Fat LossPhase 4NCT06541899

Safety and Efficacy of Cryolipolysis Clinical Protocols

A Phase 4 study testing Polarys Cryolipolysis in people with Fat Loss, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A single-arm, multicenter interventional clinical study will be conducted. The objective is to evaluate the safety and efficacy of the cryolipolysis technique. Approximately 372 participants will be included. Read more about this study

Who is it for?
Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Fat Loss
What is being tested?
Polarys Cryolipolysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
395 participants
Where
3 sitesBrazil
Study dates
4 Oct 2023to 15 Dec 2024
Phase
Phase 4
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 22 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The participant (healthy volunteer) who has read and signed the informed consent form for the study.
  • Male or female ≥ 22 years and ≤ 65 years of age.
  • Subjects with a body mass index (BMI) of 30 or less and who have a greater volume of adipose tissue in the abdomen (except precordial region) and flanks.
  • Subject has not changed in weight more than 5% of body weight in the previous month.
  • Subject agrees to maintain his/her weight (i.e., within 5%) by not making major changes in his/her diet or exercise routine during the study.
  • Subject agrees to have photographs taken of the treatment area(s) during the scheduled periods.

Who cannot join

  • Diabetes mellitus or need to administer or known history of subcutaneous injections in the area of intended treatment (e.g. heparin, insulin) in the last month;
  • Metabolic and/or liver diseases that compromise vitamin metabolism;
  • Being pregnant or planning to become pregnant during the study period (within the next 8 months);
  • Being breast-feeding or having breast-fed in the last 6 months;
  • Having a known sensitivity to cold, such as cold urticaria, Raynaud\'s disease, chilblains (pernio) or any known condition with a response to cold exposure that limits blood flow to the skin;
  • Irritated skin or presence of dermatitis;
Show all 17Show fewer
  • Keloids or propensity for keloids in the area to be treated;
  • Having a history of hernia in the area(s) to be treated.
  • Any dermatological conditions, such as moderate to excessive skin laxity, or scarring at the location of the treatment sites that may interfere with treatment or evaluation (stretch marks are not an exclusion);
  • Have a history of a bleeding disorder or are taking any medications that, in the opinion of the investigator, may increase the risk of bruising;
  • Recent surgery at the treatment site;
  • Regular use of anti-inflammatory medications;
  • Are taking or have taken any pills or dietary supplements within the past month.
  • Invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the intended treatment area;
  • Implanted electronic devices (e.g., pacemaker);
  • Are currently enrolled in a clinical trial of any unapproved investigational drug or device.
  • Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or pose an unacceptable risk to the subject.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

  • Clinica Franciele Doneda Estetica Integrada

    Paranavaí, Paraná, 87709-180

  • UNDB

    São Luís, Maranhão, 65075-441

  • UNIFAE

    São Paulo, São Paulo, 13870-377

Other trials in Brazil

About this study

A single-arm, multicenter interventional clinical study will be conducted. The objective is to evaluate the safety and efficacy of the cryolipolysis technique. Approximately 372 participants will be included. After analyzing the items listed above, the participants in each study will be divided into 3 distinct intervention groups. The individuals included in the study will undergo anamnesis and data collection.

Read the detailed description

The participants in each study will be divided into 3 distinct intervention groups (Grupo 1: aplicador 360° M - Região abdominal; Grupo 2: aplicador 360° G - Região abdominal; Grupo 3: aplicador de placas - Região dos flancos). After analyzing the inclusion and exclusion criteria of this study, the individuals included in the study will undergo anamnesis and data collection after the procedure and 6 weeks and 20 weeks after: photographic capture, bioimpedance, perimetry, adipometry and ultrasound imaging of the treated area, in addition to a pain and patient satisfaction questionnaire.

Conditions
Fat Loss
Being tested
Polarys Cryolipolysis
Keywords
Fat Loss, Weight Loss, Cryolipolysis
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polarys CryolipolysisDevice

    Also called Cryolipolysis

    The procedure will take place in a session lasting a maximum of 60 minutes, which may vary depending on the amount of fat in the area and the type of applicator chosen (with or without vacuum). The patient will be comfortably positioned, in a position that facilitates suction/fixation of the applicator. An antifreeze membrane will be applied correctly to the skin, avoiding wrinkles. The marked skin area will be positioned in the center of the membrane. The applicator will be positioned in the treatment area at 90° to the skin and will activate the START.

Study groups in NCT06541899
Study groupRoleWhat they receive
Group 1 - 360° M applicator, abdominalExperimentalGroup 1: 360° M applicator - Abdominal region
Receives: Device: Polarys Cryolipolysis
Group 2 - 360° G applicator, abdominalExperimentalGroup 2: 360° G applicator - Abdominal region
Receives: Device: Polarys Cryolipolysis
Group 3 - flanksExperimentalGroup 3: Plate applicator - Flank region
Receives: Device: Polarys Cryolipolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocurrence of adverse events after de procedure assessed by clinical evaluation

    Adverse events such as erythema, pain, edema or any other event that occurs in correlation with the treatment, through monitoring in the reassessments stipulated in the study and also in a questionnaire answered by the patient

    Measured: After de procedure and 6 and 20 weeks after

  2. % reduction in fat layer assessed by ultrasound, adipometer and photography

    Adipometer: to measure the thickest point within the treatment area. For the evaluation in the abdominal region, reference points located 5 cm to the side of the umbilical scar, both on the right and left sides, will be recorded. For the evaluation in the flank region, the measurement will be standardized using the axillary midline, being performed exactly in the central fold of each flank; Ultrasound: subcutaneous tissue between the anatomical planes. The probe will be positioned at the points previously marked in the treatment area, following the same measurement performed for adipometry; Photography: at fixed angles and postures with standardized disposable underwear. Three-dimensional images will be taken of the subjects in sagittal (left and right sides) and coronal (front and back sides) views at baseline and at the stipulated follow-up periods. The abdominal region will be exposed and the subject will be instructed to remain still while the camera captures an image.

    Measured: Immediately after the procedure and 6 and 20 weeks after

Secondary outcomes (1)

  1. Patient"s satisfaction assessed by GAIS scale

    Patient satisfaction level will be categorized using the 5-point Global Aesthetic Improvement Scale (GAIS). It is divided into 5: "excellent", 4: "greatly improved", 3: "improved", 2: "no change" and 1: "worsened".

    Measured: 6 weeks and 20 weeks after the cryolipolysis procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study start4 Oct 2023
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06541899
Sponsor's protocol ID
Ibramed_01_2024_V1
Status last verified
Mar 2025
First submitted
31 Jul 2024
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Faulhaber J, Sandhofer M, Weiss C, Sattler G, Sadick NS. Effective noninvasive body contouring by using a combination of cryolipolysis, injection lipolysis, and shock waves. J Cosmet Dermatol. 2019 Aug;18(4):1014-1019. doi: 10.1111/jocd.12953. Epub 2019 Apr 13.

    PubMed 30980602

  • Falster M, Schardong J, Santos DPD, Machado BC, Peres A, Rosa PVD, Plentz RDM. Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial. Braz J Phys Ther. 2020 Sep-Oct;24(5):441-448. doi: 10.1016/j.bjpt.2019.07.005. Epub 2019 Jul 26.

    PubMed 31375459

  • Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, tolerance, and patient satisfaction with noninvasive cryolipolysis. Dermatol Surg. 2013 Aug;39(8):1209-16. doi: 10.1111/dsu.12238. Epub 2013 May 2.

    PubMed 23639062

  • Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009 Jul;33(4):482-8. doi: 10.1007/s00266-008-9286-8. Epub 2009 Mar 19.

    PubMed 19296153

  • Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg. 2014 Sep;40(9):1004-9. doi: 10.1097/01.DSS.0000452628.99209.4f.

    PubMed 25111437

  • Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med. 2014 Dec;46(10):731-5. doi: 10.1002/lsm.22302. Epub 2014 Nov 13.

    PubMed 25395266

  • Bernstein EF, Bloom JD. Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening. JAMA Facial Plast Surg. 2017 Sep 1;19(5):350-357. doi: 10.1001/jamafacial.2017.0102.

    PubMed 28426847

  • Abdel-Aal NM, Elerian AE, Elmakaky AM, Alhamaky DMA. Systemic Effects of Cryolipolysis in Central Obese Women: A Randomized Controlled Trial. Lasers Surg Med. 2020 Dec;52(10):971-978. doi: 10.1002/lsm.23250. Epub 2020 Apr 15.

    PubMed 32293044

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polarys Cryolipolysis in people with Fat Loss, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 3 sites 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocurrence of adverse events after de procedure assessed by clinical evaluation (time frame: After de procedure and 6 and 20 weeks after). 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 NCT06541899, which also lists 8 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 25 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in