Clinical trial NCT06421207: Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.
Official title: Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor® Micro-Coring™ Procedure in an Abdominoplasty Model.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histopathology
Wrinkle
Rhytides
Keywords: Mechanism of Action
Micro-Coring
Abdominoplasty
histopathology
immunohistochemistry
wrinkle treatment
Lead sponsor: Cytrellis Biosystems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dallas Plastic Surgery Institute
First posted: 2024-05-20
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Abdominoplasty model
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 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).
measure: The change in histopathology of abdominoplasty tissue samples after a single treatment with the ellacor® device at depths of 4mm, 5mm and 7mm as compared to an untreated control area.
timeFrame: Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacor® treatment.
measure: The change in histopathology of abdominoplasty tissue after 1, 2 and 3 ellacor® 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.
timeFrame: The histopathological studies will be performed on the excised abdominoplasty tissue approximately 90 days after the first ellacor® treatment, 60 days after the second treatment and 30 days after the final treatment is performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
affiliation: Dallas Plastic Surgery Institute
name: Rod Rohrich, MD
role: PRINCIPAL_INVESTIGATOR
References: