Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 3:07 PM
Study NCT ID:
NCT05665335
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
Sponsor:
Apyx Medical
Organization:
Study Overview
Official Title:
A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system.
Procedure data and adverse events will be captured.
Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.
At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system.
Procedure data and adverse events will be captured.
Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: