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:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT05665335
Eligibility Criteria:
Inclusion Criteria:
* Female subjects, ages 18 - 75 years old.
* ASA Physical Status Classification System Class I and Class II subjects.
* Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
* Breast Cup Size A and Size B.
* Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
* Absence of physical conditions unacceptable to the investigator.
* Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
* Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
* Willing to release rights for the use of study photos, including in publication.
* Able to read, understand, sign, and date the informed consent.
* Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
Exclusion Criteria:
* Subjects presenting with ASA Physical Status Classification System Classes III or higher.
* Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
* Breast Cup Size C, Size D or larger.
* Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.).
* Pregnant, lactating, or plans to become pregnant during study participation.
* Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
* Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
* Previous treatment in the study treatment area.
* Active systemic or local skin disease that may alter wound healing.
* Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
* History of autoimmune disease (excluding Hashimoto's thyroiditis).
* Known susceptibility to keloid formation or hypertrophic scarring.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Possesses a surgically implanted electronic device (i.e., pacemaker).
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
* Participation in any other investigational study within 30 days prior to consent and throughout study participation.
* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05665335
Study Brief:
Protocol Section:
NCT05665335