ClinicalTrials.gg
CompletedNCT07224880Updated Oct 5, 2026

Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists

An observational study in glp1 Agonist, Gene Expression and Skin Laxity, sponsored by Cytrellis Biosystems, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Cytrellis Biosystems, Inc. · Observational

Updated Oct 5, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
9
Ages
30 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.

Enrollment
71st of 76
9 · median 99
Started
2025
with 54 others
Observational
77 of 995
18 open now
Registered
946th of 995
by date

Among the 995 studies in Weight Loss with a site in United States, this one is the 71st largest by enrollment of the 76 observational ones that give a count, is one of 55 that started in 2025, is one of 77 observational ones, and was the 946th registered.

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

Browse Weight Loss studies →

Open to participants now

114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:

109 more — sign in →

All 114 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.

This study: 30 Years to 65 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 995 studies in Weight Loss with a site in United States, or all of them as a file.
02

Study summary

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

Read the detailed description

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).

03

Conditions studied

  • glp1 Agonist
  • Gene Expression
  • Skin Laxity

Browse trials for

Keywords

  • ellacor
  • GLP-1
  • weight loss
04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female adult, between the ages of 30 and 65
  2. Fitzpatrick Skin Type I-VI
  3. Have moderate to severe wrinkles on the mid and lower face, according to Lemperle Wrinkle Severity Scale (LWSS), i.e. score 3, 4 or 5.
  4. Have moderate to extreme abdominal laxity according to Stokes Scale (i.e., score of 2-4 on a scale of 0-4).
  5. Willingness to sign Form

Exclusion criteria

Exclusion Criteria:

  1. Pregnant women or nursing mothers
  2. Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
  3. Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
  4. Patients with a history or presence of any bleeding disorder
  5. Patients with dermatological or conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus
  6. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or infection)
  7. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days
  8. Patients who are on courses of chemotherapy, high-dose use, or radiation in the treatment area
  9. Patients with have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old
  10. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months
  11. Patients with scars less than six (6) months old in the treatment area
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • GLP1 Patients

    Patients have lost at least 10% of their baseline body weight from taking a GLP-1 receptor agonist

    Device: ellacor

Interventions

  • Deviceellacor

    dermal non-thermal micro-coring device

    Also known as: micro-coring, dermal micro-coring

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: study time frame

07

Study locations

1 site
  • Tri Valley Plastic Surgery
    Dublin, California 94568, United States
08

References and documents

Publications

  • 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. PubMed 38841534 ↗
  • 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. PubMed 36262685 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2025 to primary completion in Aug 2026, 10 months.

Of 92 observational studies under Weight Loss, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 99. This study's 10 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: primary completion Jan 2026 → Aug 2026 and completion Feb 2026 → Aug 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2025
First posted
Nov 5, 2025
StartActual
Oct 14, 2025
Primary completionActual
Aug 21, 2026was Jan 2026
CompletionActual
Aug 21, 2026was Feb 2026
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 5, 2026
Primary completion
Jan 30, 2026→Aug 21, 2026 (actual)
Oct 5, 2026
Study completion
Feb 28, 2026→Aug 21, 2026 (actual)
Oct 5, 2026
Enrollment
10 (estimated)→9 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Recruiting→Completed
    Primary completion Jan 30, 2026→Aug 21, 2026 (now actual)
    Study completion Feb 28, 2026→Aug 21, 2026 (now actual)
    Enrollment 10 (estimated)→9 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07224880
Lead sponsor
Cytrellis Biosystems, Inc.
Responsible party
Sponsor
First posted
Nov 5, 2025
Start date
Oct 14, 2025
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026
Last update
Oct 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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