A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvio… (NCT05665335) | Clinical Trial Compass
CompletedNot Applicable
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
Greece15 participantsStarted 2022-11-28
Plain-language summary
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.…
What they're measuring
1
Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.