Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.

Cytrellis

Status: Completed

Conditions: Histopathology; Rhytides; Wrinkle

Treatments: Device: ellacor® Micro-Coring procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06421207

TP-00379

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Undergoing planned abdominoplasty
• Are willing to donate their tissue for evaluation
• BMI ≤ 30
• Women 18 years or older
• Fitzpatrick scale I-VI
• Females of childbearing potential will have a negative urine pregnancy test prior to each procedure
• Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening
• Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site.
• Able and willing to comply with all visits, procedures and evaluation schedules and requirements

Exclusion criteria

• Having an active bleeding disorder or currently taking anticoagulants
• History of keloid formation or abnormal wound healing
• Inflammation or active infection and treatment area
• Compromised immune system (e.g., diabetes)
• Any surgery or treatments in the abdominal area 12 months prior to procedure
• Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements
• Pregnant or breastfeeding
• Tattoo and/or mole located within the planned treatment area(s)
• Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons
• Any issue that at the discretion of the investigator would contraindicate the subject's participation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Cohort 1 Safety Evaluation of Treatment Depths

Active Comparator group

Description:

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).

Treatment:

Device: ellacor® Micro-Coring procedure

Cohort 2 Multiple Treatment Histology

Active Comparator group

Description:

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).

Treatment:

Device: ellacor® Micro-Coring procedure