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| Name | Class |
|---|---|
| Dallas Plastic Surgery Institute | OTHER |
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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:
The ellacorĀ® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacorĀ® 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 ellacorĀ® procedure done 30 days before their abdominoplasty surgery. The ellacorĀ® 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 ellacorĀ® 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 ellacorĀ® device to an area left untreated. This will reveal any changes in the skin tissue between treated and untreated areas, if they occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Safety Evaluation of Treatment Depths | Active Comparator | Each subject will be treated a single time at 4mm, 5mm and 7 mm depths at a minimum of 3 treatment areas. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after treatment (Day 30). |
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| Cohort 2 Multiple Treatment Histology | Active Comparator | Each subject will be treated at a specified depth (4mm). Treatment area 1 will have 3 treatments with the study device, each treatment 30 days apart starting on Day 0. Treatment area 2 will have 2 treatments with the study device 30 days apart starting on Day 30. Treatment area 3 will have a single treatment with the study device on Day 60. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after the area 3 treatment (Day 90). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ellacorĀ® Micro-Coring procedure | Device | ellacorĀ® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | The incidence and severity of adverse events will be evaluated for both Study Cohorts. | Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 30 for Cohort 1 or Day 90 for Cohort 2). |
| The change in histopathology of abdominoplasty tissue samples after a single treatment with the ellacorĀ® device at depths of 4mm, 5mm and 7mm as compared to an untreated control area. | Compare histopathology of stained tissue isolated after a single ellacorĀ® treatment on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue following abdominoplasty. Tissue will have an untreated control area compared to three treated areas wherein the depth of treatment will be 4mm, 5mm, and 7mm. The evaluation will include staining with: Hematoxylin and Eosin (H&E), Herovici, and Movat stains. The use of these stains will provide a comparison of the structural tissue changes (H&E stain), change in the presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings. | Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacorĀ® treatment. |
| The change in histopathology of abdominoplasty tissue after 1, 2 and 3 ellacorĀ® treatments (depth of 4mm) compared to untreated control area. Treatments are separated by 30 days with a final tissue comparison 90 days after the first treatment. | Evaluate the comparative histopathology of tissue isolated after multiple treatments on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue after abdominoplasty. Tissue will have an untreated control area compared to three treated areas. Area 1 will have 3 treatments. Area 2 will have 2 treatments. Area 3 will have treatment. The evaluation will include staining with: Hematoxylin and Eosin, Herovici, and Movat stains. These stains will provide comparison of the structural tissue change (H&E stain), change in the presence of Type III (young) and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to the untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings. |
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Inclusion Criteria:
Exclusion Criteria:
Self-representation.
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| Name | Affiliation | Role |
|---|---|---|
| Rod Rohrich, MD | Dallas Plastic Surgery Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2026 | Feb 23, 2026 | 1 | ||
| Mar 16, 2026 |
Abdominoplasty model
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| The histopathological studies will be performed on the excised abdominoplasty tissue approximately 90 days after the first ellacorĀ® treatment, 60 days after the second treatment and 30 days after the final treatment is performed. |
| Apr 3, 2026 |
| 2 |