Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502470
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open Label Study to Explore Healing and Tissue Histopathology Following Ellacor Micro-Coring Procedures in an Abdominoplasty Model
Status:
COMPLETED
Status Verified Date:
2024-07
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:
The goal of this study is to observe the healing of skin after ellacor treatment at different timepoints depths and coring densities The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor procedure works to induce skin resurfacing 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
How does human skin change after a series of the ellacor procedures over a 14-day period
Is the ellacor device safe to use at different treatment time points depths and densities
The ellacor procedure will be performed on people who are going to have abdominoplasty surgery The ellacor treatment areas will be limited to the skin areas marked for removal 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 the study
The 3 participants will have the ellacor procedure done at 4 different timepoints before their abdominoplasty surgery -14 days -7 days -3 days and on day 0 just prior to the abdominoplasty procedure At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5 7 and 8 The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day 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 which is the control area This will reveal by visual comparison any changes in the skin tissue between treated and untreated areas if they occur
The main questions this study aims to answer are
How does human skin change after a series of the ellacor procedures over a 14-day period
Is the ellacor device safe to use at different treatment time points depths and densities
The ellacor procedure will be performed on people who are going to have abdominoplasty surgery The ellacor treatment areas will be limited to the skin areas marked for removal 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 the study
The 3 participants will have the ellacor procedure done at 4 different timepoints before their abdominoplasty surgery -14 days -7 days -3 days and on day 0 just prior to the abdominoplasty procedure At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5 7 and 8 The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day 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 which is the control area This will reveal by visual comparison 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?:
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