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Procedure

Renuvion for Loose Skin

N/A
Waitlist Available
Led By Dan Albershardt
Research Sponsored by Apyx Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of subcutaneous soft tissue. Patients undergoing procedures involving Renuvion alone and/or Renuvion following liposuction will be included.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 365
Awards & highlights

Study Summary

This trial studies the effects of a treatment using a Renuvion system after liposuction in the abdomen. Images and measurements will be taken before and during treatment. Follow-up images and measurements will be taken for 1 year.

Who is the study for?
This trial is for individuals planning to undergo Renuvion treatment after liposuction on the abdomen, who are in good heart and lung health, can follow study procedures, and consent to use of their photos. It's not for those with certain connective tissue diseases, a BMI over 35, uncontrolled diabetes, smokers or nicotine users.Check my eligibility
What is being tested?
The study tests how well the Renuvion APR Handpiece tightens loose skin when used after liposuction. Ultrasound images will measure soft tissue contraction before and during treatment at multiple time points up to one year post-procedure.See study design
What are the potential side effects?
While specific side effects aren't listed here, all adverse events related to the procedure will be recorded. These could include typical reactions from similar cosmetic procedures such as swelling, bruising, pain at the site of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure using Renuvion to tighten my skin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of contraction
Secondary outcome measures
Energy Delivered
IPR Review
Patient Satisfaction
+2 more
Other outcome measures
Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renuvion APR System TreatmentExperimental Treatment1 Intervention
Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time.

Find a Location

Who is running the clinical trial?

Apyx MedicalLead Sponsor
9 Previous Clinical Trials
353 Total Patients Enrolled
Dan AlbershardtPrincipal InvestigatorInvestigator
Chris NicholsPrincipal InvestigatorInvestigator

Media Library

Renuvion APR Handpiece (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05968495 — N/A
Loose Skin Research Study Groups: Renuvion APR System Treatment
Loose Skin Clinical Trial 2023: Renuvion APR Handpiece Highlights & Side Effects. Trial Name: NCT05968495 — N/A
Renuvion APR Handpiece (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968495 — N/A

Frequently Asked Questions

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

Does this trial admit individuals of advanced age?

"Adherence to the eligibility criteria of this medical trial necessitates that participants are over 18 years old and under 65."

Answered by AI

Are there any criteria that disqualify a person from entering this trial?

"This medical trial will admit a maximum of 5 people who possess lax skin and are between 18-65 years old."

Answered by AI

Has this research endeavor begun to recruit participants yet?

"Affirmative. The information accessible on clinicaltrials.gov attests to this medical study's active recruitment status; it was initially posted on June 1st 2023 and most recently updated July 27th 2023. They are looking for 5 participants from a single site."

Answered by AI

How many individuals have been enrolled in this clinical investigation?

"Affirmative. The clinical trial's page on clinicaltrials.gov affirms that the study is still looking for volunteers, with 5 needed from a single site since it was first posted June 1st 2023 and last updated on July 27th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Pearl Plastic Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
2023. "Measuring Renuvion Soft Tissue Contraction Using Ultrasound". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968495.
~2 spots leftby Sep 2024
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