Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421207
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-01-29
Brief Title:
Open Label Study Exploring Tissue Histopathology After Ellacor Procedure in an Abdominoplasty Model
Sponsor:
Cytrellis Biosystems Inc
Organization:
Cytrellis Biosystems Inc
Study Overview
Official Title:
Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor Micro-Coring Procedure in an Abdominoplasty Model
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The goal of this study to better understand how the ellacor Micro-Coring procedure works using an abdominoplasty or tummy tuck surgery model The people participating in the study will have already decided that they want to have an abdominoplasty procedure
The main questions this study aims to answer are
1 how does the ellacor procedure change skin tissue
2 is the ellacor device safe to use at specific treatment depths
The ellacor procedure will be performed on people who are going to have abdominoplasty surgery The ellacor treatment areas will be limited to the areas marked for removal of skin during the abdominoplasty The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete A minimum of 3 people will be treated in each of 2 groups for a total of 6 total participants
3 participants in the first group will have the ellacor procedure done 30 days before their abdominoplasty surgery The ellacor procedure will be done at different depths in designated locations 4mm 5mm and 7mm The participants will be asked about any changes to their health or medications while on the study
3 participants in the second group will have the ellacor procedure done at 3 different timepoints 30 days apart all at the same depth of 4mm They will also be asked about any changes to their health or medications while on the study
Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants They will compare the areas treated by the ellacor device to an area left untreated This will reveal any changes in the skin tissue between treated and untreated areas if they occur
The main questions this study aims to answer are
1 how does the ellacor procedure change skin tissue
2 is the ellacor device safe to use at specific treatment depths
The ellacor procedure will be performed on people who are going to have abdominoplasty surgery The ellacor treatment areas will be limited to the areas marked for removal of skin during the abdominoplasty The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete A minimum of 3 people will be treated in each of 2 groups for a total of 6 total participants
3 participants in the first group will have the ellacor procedure done 30 days before their abdominoplasty surgery The ellacor procedure will be done at different depths in designated locations 4mm 5mm and 7mm The participants will be asked about any changes to their health or medications while on the study
3 participants in the second group will have the ellacor procedure done at 3 different timepoints 30 days apart all at the same depth of 4mm They will also be asked about any changes to their health or medications while on the study
Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants They will compare the areas treated by the ellacor device to an area left untreated This will reveal any changes in the skin tissue between treated and untreated areas if they occur
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None