Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656923
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Analyze Previously Collected Biopsy Samples From Participants Who Completed the SPLASH Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PLLA-ADIPOGENESIS-IFA Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective use immunofluorescence IF on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid PLLA or saline
Detailed Description:
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study It aims to analyze previously collected biopsy samples from participants who completed the SPLASH Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell study The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA poly-L-lactic acid We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None