Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.

Launched by CYTRELLIS BIOSYSTEMS, INC. · May 15, 2024

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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

Trial Officials