Skip to main content
OpenTrials
Completed

NCT Number: NCT05605691

Post-Market Lower Eyelid Treatment With Renuvion in Greece

This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metropolitan General Hospital

Athens, 15562, Greece

About this study

This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.

At baseline, images will be taken utilizing the site's camera system. Baseline images will be used as comparator images for follow-up images for Independent Photographic Reviewer evaluation and subject/investigator assessments.

The treatment area will be tumesced with 20 - 25ml of fluid on each side of the periorbital area.

The treatment of the periorbital area will be accessed from an incision placed in the crease of the lower lid. Two incisions will be placed in both the medial and lateral crease of the lower lid. Treatment will be performed through one incision and the second incision will be used to allow for adequate venting of helium gas. Care will be taken to undermine the tissue and to ensure the incisions communicate with each other to allow adequate venting. An optional third lower lid incision may be made as needed. The treatment plane will be above the orbicularis muscle. The treatment settings will be 20% Power, 1 LPM, and 3 Passes. Procedure data and adverse events will be captured.

Follow-up will occur 1 day, 3 days, 7 days, 30 days, 90 days, and 180 days post-procedure; images will be taken at all visits. Investigator/subjects assessments will be completed at D30, D90, and D180 visits. Subjects may also be seen back for follow-up at the investigator's discretion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects, ages 18 - 75 years old.
  • ASA Physical Status Classification System Class I and Class II subjects.
  • Complaint of skin laxity or lines in the lower eyelid area.
  • Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
  • Absence of physical conditions unacceptable to the investigator.
  • Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
  • Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
  • Willing to release rights for the use of study photos, including in publication.
  • Able to read, understand, sign, and date the informed consent.
  • Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.

Exclusion criteria

  • Subjects presenting with ASA Physical Status Classification System Classes III or higher.
  • Festoons in the periorbital area.
  • Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.
  • Pregnant, lactating, or plans to become pregnant during study participation.
  • Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
  • Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
  • Previous surgery in the study treatment area.
  • Active systemic or local skin disease that may alter wound healing.
  • Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
  • History of autoimmune disease (excluding Hashimoto's thyroiditis).
  • Known susceptibility to keloid formation or hypertrophic scarring.
  • Cancerous or pre-cancerous lesions in the area to be treated.
  • Possesses a surgically implanted electronic device (i.e., pacemaker).
  • Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
  • Participation in any other investigational study within 30 days prior to consent and throughout study participation.
  • Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Treatment and study plan

Renuvion APR System

Device

The Renuvion Generator (K192867) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The Renuvion APR Handpiece (K191542) is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

Together, the Renuvion Generator and Handpiece are referred to as the Renuvion APR System.

Primary outcomes

  1. Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.

    Time frame: 180-Day

    Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site's 2D camera system.

Secondary outcomes

  1. Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.

    Time frame: 90-Day

    Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site's 2D camera system.

Other outcomes

  1. Snap-Back Test Grade Analysis of Change From Baseline to Day 30

    Time frame: 30-Day

    This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).

  2. Snap-Back Test Grade Analysis of Change From Baseline to Day 90

    Time frame: 90-Day

    This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).

  3. Snap-Back Test Grade Analysis of Change From Baseline to Day 180

    Time frame: 180-Day

    This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).

  4. Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30

    Time frame: 30-Day

    This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (>3mm displacement), Grade IV (does not return to baseline after release and blinking).

  5. Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90

    Time frame: 90-Day

    This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (>3mm displacement), Grade IV (does not return to baseline after release and blinking).

  6. Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180

    Time frame: 180-Day

    This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (>3mm displacement), Grade IV (does not return to baseline after release and blinking).

  7. Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30

    Time frame: 30-Day

    This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (>6mm displacement), Grade IV (does not return to baseline after release and blinking).

  8. Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90

    Time frame: 90-Day

    This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (>6mm displacement), Grade IV (does not return to baseline after release and blinking).

  9. Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180

    Time frame: 180-Day

    This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (>6mm displacement), Grade IV (does not return to baseline after release and blinking).

  10. Subject Modified Global Aesthetic Improvement Scale (GAIS)

    Time frame: 90-Day

    The subject will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.

  11. Subject Modified Global Aesthetic Improvement Scale (GAIS)

    Time frame: 180-Day

    The subject will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.

  12. Investigator Modified Global Aesthetic Improvement Scale (GAIS)

    Time frame: 90-Day

    The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.

  13. Investigator Modified Global Aesthetic Improvement Scale (GAIS)

    Time frame: 180-Day

    The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.

  14. Day 180 Patient Satisfaction Questionnaire (PSQ)

    Time frame: 180-Day

    At Day 180 Follow-Up visit, the study subjects will be asked to complete a subject satisfaction survey referring to the assessment of baseline photos, current photos, and a hand mirror. Yes/No - did you notice any improvement in your lower eyelid area? If yes, checkbox - improvement in wrinkles, less sagging skin, smother skin texture, other. How would you characterize your satisfaction with the treatment - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - would you recommend this treatment to your friends and family members.

  15. Average Pain at Procedure Day Reported by Subject

    Time frame: Procedure Day 0 Following Study Treatment (within 60 minutes post procedure)

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  16. Average Pain at Day 1 Reported by Subject

    Time frame: 1-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  17. Average Pain at Day 3 Reported by Subject

    Time frame: 3-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  18. Average Pain at Day 7 Reported by Subject

    Time frame: 7-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  19. Average Pain at Day 30 Reported by Subject

    Time frame: 30-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  20. Average Pain at Day 90 Reported by Subject

    Time frame: 90-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

  21. Average Pain at Day 180 Reported by Subject

    Time frame: 180-Day

    Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"

Sponsors and collaborators

Lead sponsor

Apyx Medical

Industry

Registry information

Official study title

A Post-Market Study In Greece Of A Minimally Invasive Lower Eyelid Treatment Utilizing The Renuvion System

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.