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The main purpose of the study is to collect information about how the device functions in a variety of treatment areas and skin types and to find out what changes, if any, occur in the skin treated with the study device compared to the skin that wasn't treated including patients receiving GLP-1's, a class of medications that mimic a natural hormone to help control blood sugar and support weight loss. The study will also evaluate side effects that occur with this treatment, if any. Standardized 2D Imaging will be used to quantify reduction of wrinkle severity
This device has been approved for sale by the United States Food and Administration (FDA) for use in treatment of moderate and severe wrinkles in the mid and lower face. This device is not currently approved by the FDA for use in other locations or for other indications. The study device uses specially designed hollow coring needles, that when inserted in the tissue remove cores the size of the needle inner diameter. The tissue cores are then removed from the needle and pulled out by suction. Compared to micro-needling procedures that only puncture the skin without removing any tissue, the ellacor Micro-Coring procedure needle removes full thickness cores of skin with diameters in the range of 400 microns (0.4 millimeters or about 4 times as wide as a human hair). Skin that is removed with the ellacor Micro-Coring Technology is below the size limit that causes visible scar formation. After study treatment with the MicroCoring Technology, the areas undergo a process of repair including the formation of new collagen and elastin fibers that are typical of healthy tissue.
A minimum of 10 and maximum of 30 people will participate in this study at Tri Valley Plastic Surgery. Tri Valley Plastic Surgery is the only center participating in this study. Each person in this study will receive the same number of ellacor® treatments The study will last up to 3 months (90 days) for each person participating. There will be a minimum of 6 study visits: a Screening & Enrollment Visit followed by 1 ellacor treatment visit and 4 followup visits (Day 3, Day 7, Day 30, and Day 90); there may be an addition follow-up visit as needed according to you and your doctor. Each visit is estimated to take 30 to 90 minutes. Your participation in the study ends on the Day 90 follow-up visit. Your screening visit and your first ellacor treatment visit could occur on the same day. If this happens then your participation in the study will be about 3 months (90 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP1 Patients | Patients have lost at least 10% of their baseline body weight from taking a GLP-1 receptor agonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ellacor | Device | dermal non-thermal micro-coring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Outcomes | Safety and Efficacy of ellacor treatment in participants with FST I-VI, inclusive of participants following treatment with GLP-1 RA There will be follow-up appointments after the initial screening and enrollment visit. Each of the assessments at follow up days are specified below: Baseline or Day 0 Day 3 Day 7 Day 30 through study completion, up to Day 90 | study time frame |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult male and female participants aged between 30 to 65 years, with FST I-VI, with moderate to severe mid to lower face wrinkles and/or abdominal skin laxity as a result of excessive weight loss. They have chosen to participate in this study as evidenced by execution of the informed consent document.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karyn Siemasko, PhD | Contact | 949-394-0585 | ksiemasko@cytrellis.com | |
| Delia Khayat, PharmD | Contact | 305-484-4948 | dkhayat@cytrellis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri Valley Plastic Surgery | Recruiting | Dublin | California | 94568 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38841534 | Background | Subedi SK, Ganor O. Considerations for the Use of Fitzpatrick Skin Type in Plastic Surgery Research. Plast Reconstr Surg Glob Open. 2024 Jun 5;12(6):e5866. doi: 10.1097/GOX.0000000000005866. eCollection 2024 Jun. No abstract available. | |
| 36262685 | Background | Gfrerer L, Kilmer SL, Waibel JS, Geronemus RG, Biesman BS. Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles. Plast Reconstr Surg Glob Open. 2022 Oct 17;10(10):e4547. doi: 10.1097/GOX.0000000000004547. eCollection 2022 Oct. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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Extracted cores may be retained in the tubing.
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |