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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05329493
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent to participate in the study.
* Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment.
* All Fitzpatrick Skin Types are eligible
* General good health confirmed by medical history and skin examination of the area to be treated
* Subjects fifth finger is 17-23mm in diameter at the distal phalanges.
Exclusion Criteria:
* • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.
* Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia
* 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.
* Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
* History of keloid scarring, abnormal wound healing and /or prone to bruising.
* History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
* Any other condition 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:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05329493
Study Brief:
Protocol Section:
NCT05329493