Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cytrellis Biosystems, Inc.
With
Dallas Plastic Surgery Institute
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Undergoing planned abdominoplasty
Are willing to donate their tissue for evaluation
BMI ≤ 30
Women 18 years or older
Fitzpatrick scale I-VI
Females of childbearing potential will have a negative urine pregnancy test prior to each procedure
Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening
Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site.
Able and willing to comply with all visits, procedures and evaluation schedules and requirements
You may not be if
Having an active bleeding disorder or currently taking anticoagulants
History of keloid formation or abnormal wound healing
Inflammation or active infection and treatment area
Compromised immune system (e.g., diabetes)
Any surgery or treatments in the abdominal area 12 months prior to procedure
Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements
Pregnant or breastfeeding
Tattoo and/or mole located within the planned treatment area(s)
Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons
Any issue that at the discretion of the investigator would contraindicate the subject's participation
Clareo Health | Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
