Post Market Usability Evaluation Of The PicoSure Pro Device

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Cynosure, Inc.
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Updated on 19 February 2024
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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.

Description

Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 100 subjects will be enrolled at up to 4 study centers. Subjects will be enrolled into one of the 3 groups; Group A, Group B, or Group C.

Details
Condition Tattoo Removal, Skin Wrinkling, Benign Dermal Pigmented Lesions, Benign Epidermal Pigmented Lesions, Skin Aging, Acne Scars
Age 18years - 100years
Treatment PicoSure Pro Device, PicoSure Device, Topical Cosmeceuticals
Clinical Study IdentifierNCT05102617
SponsorCynosure, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study
The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation
Cautionary Criteria
Has unprotected sun exposure within four weeks of treatment, including the use of tanning beds or tanning products, such as creams, lotions and sprays may interfere with the laser treatment; Investigator discretion is required to determine feasibility of treatment administration
Has a coagulation disorder or is currently using anti-coagulation medications. Anticoagulants may cause excessive bleeding and interfere with posttreatment healing; Investigator discretion is required to determine feasibility of treatment administration for subjects taking anticoagulants
Is taking medications that alter the wound-healing response which may interfere with posttreatment healing and may require special precautions to be taken by a treating Investigator
Is known to have a history of healing problems or history of keloid formation, Investigator discretion is required to determine the feasibility of treatment administration
Has a history of skin cancer or suspicious lesions, Investigator discretion is required to determine feasibility of treatment administration
Has had a chemical or mechanical epilation within the last six weeks may interfere with the post treatment healing process; Investigator discretion is required to determine feasibility of treatment administration
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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