HistopathologyNCT06421207
Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.
A study testing ellacor® Micro-Coring procedure in people with Histopathology and Wrinkle, run by Cytrellis Biosystems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Histopathology, Wrinkle, Rhytides
- What is being tested?
- ellacor® Micro-Coring procedure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 4 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
About this study
Official title: Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor® Micro-Coring™ 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 answer are:
Read more
- how does the ellacor® procedure change skin tissue?
- 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
- Histopathology, Wrinkle, Rhytides
- Being tested
- ellacor® Micro-Coring procedure
- Keywords
- Mechanism of Action, Micro-Coring, Abdominoplasty, histopathology, immunohistochemistry, wrinkle treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ellacor® Micro-Coring procedureDevice
ellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Safety Evaluation of Treatment Depths | Active comparator | 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). Receives: Device: ellacor® Micro-Coring procedure |
| Cohort 2 Multiple Treatment Histology | Active comparator | 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). Receives: Device: ellacor® Micro-Coring procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
The incidence and severity of adverse events will be evaluated for both Study Cohorts.
Measured: 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).
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.
Compare histopathology of stained tissue isolated after a single ellacor® treatment on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue following abdominoplasty. Tissue will have an untreated control area compared to three treated areas wherein the depth of treatment will be 4mm, 5mm, and 7mm. The evaluation will include staining with: Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The use of these stains will provide a comparison of the structural tissue changes (H\&E stain), change in the presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
Measured: Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacor® treatment.
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.
Evaluate the comparative histopathology of tissue isolated after multiple treatments on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue after abdominoplasty. Tissue will have an untreated control area compared to three treated areas. Area 1 will have 3 treatments. Area 2 will have 2 treatments. Area 3 will have treatment. The evaluation will include staining with: Hematoxylin and Eosin, Herovici, and Movat stains. These stains will provide comparison of the structural tissue change (H\&E stain), change in the presence of Type III (young) and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to the untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start22 Feb 2023
- Primary completion19 Jun 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistopathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Abdominoplasty model
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dallas Plastic Surgery Institute
- Responsible party
- Sponsor
- Investigators
- Rod Rohrich, MD, Principal investigator, Dallas Plastic Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421207
- Sponsor's protocol ID
- TP-00379
- Status last verified
- May 2024
- First submitted
- 29 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor® Micro-Coring™ Procedure in an Abdominoplasty Model.
- ClinicalTrials.gov ID
- NCT06421207
- Acronym / sponsor ID
- TP-00379
- Conditions
- Histopathology, Wrinkle, Rhytides
- Keywords
- Mechanism of Action, Micro-Coring, Abdominoplasty, histopathology, immunohistochemistry, wrinkle treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dallas Plastic Surgery Institute
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- how does the ellacor® procedure change skin tissue?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Abdominoplasty model
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Safety Evaluation of Treatment Depths | Active comparator | Device: ellacor® Micro-Coring procedureEach 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). |
| Cohort 2 Multiple Treatment Histology | Active comparator | Device: ellacor® Micro-Coring procedureEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Undergoing planned abdominoplasty
- Are willing to donate their tissue for evaluation
- BMI ≤ 30
- Women 18 years or older
- Fitzpatrick scale I-VI
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ellacor® Micro-Coring procedureellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. | Device | Cohort 1 Safety Evaluation of Treatment Depths, Cohort 2 Multiple Treatment Histology |
Primary outcome
Incidence and severity of adverse events
Time frame: 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).
The incidence and severity of adverse events will be evaluated for both Study Cohorts.
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.
Time frame: Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacor® treatment.
Compare histopathology of stained tissue isolated after a single ellacor® treatment on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue following abdominoplasty. Tissue will have an untreated control area compared to three treated areas wherein the depth of treatment will be 4mm, 5mm, and 7mm. The evaluation will include staining with: Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The use of these stains will provide a comparison of the structural tissue changes (H\&E stain), change in the presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
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.
Time frame: 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.
Evaluate the comparative histopathology of tissue isolated after multiple treatments on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue after abdominoplasty. Tissue will have an untreated control area compared to three treated areas. Area 1 will have 3 treatments. Area 2 will have 2 treatments. Area 3 will have treatment. The evaluation will include staining with: Hematoxylin and Eosin, Herovici, and Movat stains. These stains will provide comparison of the structural tissue change (H\&E stain), change in the presence of Type III (young) and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to the untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rod Rohrich, MD principal investigator
Dallas Plastic Surgery Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ellacor® Micro-Coring procedure in people with Histopathology and Wrinkle, run by Cytrellis Biosystems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.