Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device's capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.
Part 1 Pre-Clinical Study Procedure:
Part 2 Clinical Study Procedure:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Pre-Clinical Procedure | Experimental |
|
|
| Part 2 Clinical Study Procedure | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation | Device | Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| TUNEL Staining | Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) is a robust technique for detecting apoptosis or cell death. Fluorescence intensity of the TUNEL positive cells in the treatment groups compare to control (untreated) will be measured. The data is given as fold change or percentage. | Up to 30 days |
| Mason's Trichrome | The structural analysis using Trichrome will be observational to demonstrate any deviation from the normal skin structure (descriptive tool). | Up to 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shlomo Assa, President FACorp | FA Corporation | Study Director |
| Jeffrey Kenkel, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Soutwestern Medical Center | Dallas | Texas | 75390 | United States |
We are unsure of the current publication plan for this clinical study data. Due to IP and confidentiality we would like to request this filing remain private.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation | Device | Healing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty. |
|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |