Post Market Usability Evaluation Of The PicoSure Pro Device (NCT05102617) | Clinical Trial Compass
CompletedNot Applicable
Post Market Usability Evaluation Of The PicoSure Pro Device
United States23 participantsStarted 2021-10-21
Plain-language summary
The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* A healthy male or female 18 years of age or older.
* Willing to undergo treatments with the PicoSure and PicoPro devices for pigmentary lesions, acne scars, skin revitalization, or tattoo removal.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion Criteria:
* Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
* The subject is hypersensitive to light in the near infrared wavelength region.
* The subject takes medication which is known to increase sensitivity to sunlight.
* The subject has seizure disorders triggered by light.
* The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
* The subject has an active localized or systemic infection, or an open wound in area being treated.
* The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
* The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
* The subject has herpes simplex in the area being treated.
* The subject is receiving or has received gold therapy.
* The subject is currently enrolled in…