Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT04876118
Eligibility Criteria:
Inclusion Criteria
* Female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
* Subject has not had weight change exceeding 5% in the preceding month.
* Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has read and signed a written informed consent form.
Exclusion Criteria
* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
* Presence of significant suntan in the thighs.
* Inability to avoid sun exposure in the thighs.
* Subject has a history of hernia in or adjacent to the areas to be treated.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.
* Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol.
* Subject is taking or has taken diet pills or supplements within the past month.
* 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 has an active implanted device such as a pacemaker, defibrillator, implants (e.g. buttock implants), or drug delivery system.
* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT04876118
Study Brief:
Protocol Section:
NCT04876118