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NCT06502470 · ClinicalTrials.gov registry record · NA
Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
A NA study, sponsored by Cytrellis Biosystems.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT06502470 is a NA study that has completed, run by Cytrellis Biosystems. The registered enrollment target is 3 participants.
The verdict
NCT06502470, a NA study, has completed, sponsored by Cytrellis Biosystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DEVICE ellacor® Micro-Coring procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2024-05-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06502470
The ClinicalTrials.gov registry entry for NCT06502470 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cytrellis Biosystems, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ellacor® Micro-Coring procedure is the first listed.
NCT06502470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06502470 about?
NCT06502470 is a clinical study titled "Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment". 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...
What is the current status of trial NCT06502470?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2024-04-30. Estimated completion is 2024-05-17.
What interventions are being tested in trial NCT06502470?
The interventions under investigation include: ellacor® Micro-Coring procedure (DEVICE).
Who is sponsoring clinical trial NCT06502470?
This trial is sponsored by Cytrellis Biosystems, which has 8 total clinical trials registered on ClinicalTrials.gov.
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