Safety and Efficacy of Cryolipolysis Clinical Protocols

NCT06541899 | Completed Phase 4 FDA Device

• 1 other identifier: Ibramed_01_2024_V1
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Fat Loss

Keywords

Fat Loss; Weight Loss; Cryolipolysis

Outcome Measures

Primary Outcomes (2)

• 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

  After de procedure and 6 and 20 weeks after

• % 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.

  Immediately after the procedure and 6 and 20 weeks after

Secondary Outcomes (1)

• Patient"s satisfaction assessed by GAIS scale

  6 weeks and 20 weeks after the cryolipolysis procedure

Study Arms (3)

Group 1 - 360° M applicator, abdominal

EXPERIMENTAL

Group 1: 360° M applicator - Abdominal region

Device: Polarys Cryolipolysis

Group 2 - 360° G applicator, abdominal

EXPERIMENTAL

Group 2: 360° G applicator - Abdominal region

Device: Polarys Cryolipolysis

Group 3 - flanks

EXPERIMENTAL

Group 3: Plate applicator - Flank region

Device: Polarys Cryolipolysis

Interventions

Polarys Cryolipolysis DEVICE

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.

Also known as: Cryolipolysis

Group 1 - 360° M applicator, abdominal; Group 2 - 360° G applicator, abdominal; Group 3 - flanks

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Keloids or propensity for keloids in the area to be treated;
• Having a history of hernia in the area(s) to be treated.
• 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.

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (3)

UNDB

São Luís, Maranhão, 65075-441, Brazil

Location

Clinica Franciele Doneda Estetica Integrada

Paranavaí, Paraná, 87709-180, Brazil

Location

UNIFAE

São Paulo, São Paulo, 13870-377, Brazil

Location

Related Publications (8)

• 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.

  PMID: 30980602 BACKGROUND

• 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.

  PMID: 31375459 BACKGROUND

• 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.

  PMID: 23639062 BACKGROUND

• 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.

  PMID: 19296153 BACKGROUND

• 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.

  PMID: 25111437 BACKGROUND

• 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.

  PMID: 25395266 BACKGROUND

• 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.

  PMID: 28426847 BACKGROUND

• 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.

  PMID: 32293044 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 7, 2024
• Study Start: October 4, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

BR (3)