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NCT06421207 · ClinicalTrials.gov registry record · NA
Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.
A NA study of Wrinkle and Rhytides, sponsored by Cytrellis Biosystems.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06421207 is a NA study of Wrinkle and Rhytides that has completed, run by Cytrellis Biosystems. The registered enrollment target is 6 participants, below the 120-participant average among 25 other Wrinkle trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06421207, a NA study of Wrinkle and Rhytides, has completed, sponsored by Cytrellis Biosystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE ellacor® Micro-Coring procedure
Study Locations (1)
Texas
- Dallas Plastic Surgery Institute - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2023-10-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06421207
The ClinicalTrials.gov registry entry for NCT06421207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 25 other Wrinkle trials with a reported enrollment target (95% lower). The listed sponsor is Cytrellis Biosystems, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Wrinkle appearing as the primary indexed condition, and to 1 intervention - of which ellacor® Micro-Coring procedure is the first listed.
NCT06421207 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06421207 about?
NCT06421207 is a clinical study titled "Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.". 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...
What is the current status of trial NCT06421207?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2023-02-22. Estimated completion is 2023-10-04.
What conditions does trial NCT06421207 study?
This clinical trial studies the following conditions: Wrinkle, Rhytides, Histopathology.
What interventions are being tested in trial NCT06421207?
The interventions under investigation include: ellacor® Micro-Coring procedure (DEVICE).
Who is sponsoring clinical trial NCT06421207?
This trial is sponsored by Cytrellis Biosystems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06421207 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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