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Procedure

Mechanical Coring for Skin Tightening

N/A
Recruiting
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 90 (end of study)
Awards & highlights

Study Summary

This trial is testing a new method of skin tightening that uses a machine to pierce and then close the skin in a specific direction. They will be testing this on 40 people in different areas of their body to see how effective and safe it is.

Who is the study for?
This trial is for healthy adults aged 30-70 who can consent and follow the study plan. Women must use birth control and have a negative pregnancy test. Participants with any skin type are welcome, but those with darker skin (Fitzpatrick V or VI) will be limited to 25% of the group. People with recent aesthetic treatments, infections, poor healing, certain medical conditions, cancer history, allergies to specific drugs, current participation in other trials or smokers cannot join.Check my eligibility
What is being tested?
The trial tests a device called VENUS AIME (RoboCor) for directional skin tightening through mechanical coring. It's a forward-looking study conducted across up to three centers involving multiple treatment areas on the skin to assess both safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, risk of infection due to skin penetration by the device, possible allergic reactions if sensitive to materials used during procedure like tegaderm/glue application or analgesic agents used for pain management.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 90 (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 90 (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Cores Successfully Removed by Coring Device
Secondary outcome measures
Downtime, as evaluated using the Subject Questionnaire
Other outcome measures
Treatment pain

Trial Design

1Treatment groups
Experimental Treatment
Group I: Micro-coring treatmentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,298 Total Patients Enrolled
Matthew GronskiStudy DirectorVenus Concept
6 Previous Clinical Trials
110 Total Patients Enrolled
Matthew Gronski, PhDStudy DirectorVenus Concept
4 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Directional Skin Tightening (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04910945 — N/A
Skin Tightening Research Study Groups: Micro-coring treatment
Skin Tightening Clinical Trial 2023: Directional Skin Tightening Highlights & Side Effects. Trial Name: NCT04910945 — N/A
Directional Skin Tightening (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04910945 — N/A
Skin Tightening Patient Testimony for trial: Trial Name: NCT04910945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals wishing to participate in this clinical trial?

"Clinicaltrials.gov confirms the continued recruitment of patients for this medical study which was first posted in February 2021 and most recently updated two months ago."

Answered by AI

What is the maximum enrollment capacity for this experimental trial?

"Affirmative, the clinicaltrials.gov portal reveals that this experiment is actively recruiting participants. It was first made available on February 14th 2021 and has been revised as recently as November 28th 2022. The trial requires 40 volunteers across 3 centers of research."

Answered by AI

Is this research endeavor recruiting participants who are over twenty years of age?

"This clinical trial seeks patients aged 30 to 70. In contrast, there are 50 trials for minors and 371 studies that accept participants above 65 years of age."

Answered by AI

Who is eligible to enroll in this clinical trial?

"This trial is seeking 40 willing participants who have skin and are aged between 30 to 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
California
Indiana
How old are they?
18 - 65
What site did they apply to?
DeNova Research
Berman Skin Institute
Le's Aesthetics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

When does the trial begin?
PatientReceived no prior treatments

Why did patients apply to this trial?

Could use some tightened skin :). I have lost a significant amount of weight and am dealing with sagging skin on face, arms, neck,legs. I'm very interested in the Skin Tightening Trial.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Berman Skin Institute: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Mechanical Coring to Achieve Directional Skin Tightening
2021. "Mechanical Coring to Achieve Directional Skin Tightening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910945.
~21 spots leftby Aug 2025
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