Back to resultsPost-Market Lower Eyelid Treatment With Renuvion in Greece
Primary Purpose
Skin Laxity
Status
Active
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Renuvion APR System
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Periorbital
Eligibility Criteria
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.
Sites / Locations
- Metropolitan General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renuvion APR System Treatment
Arm Description
Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area.
Outcomes
Primary Outcome Measures
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
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 Outcome Measures
Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05605691
Brief Title
Post-Market Lower Eyelid Treatment With Renuvion in Greece
Official Title
A Post-Market Study In Greece Of A Minimally Invasive Lower Eyelid Treatment Utilizing The Renuvion System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apyx Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Periorbital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renuvion APR System Treatment
Arm Type
Experimental
Arm Description
Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area.
Intervention Type
Device
Intervention Name(s)
Renuvion APR System
Intervention Description
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 Outcome Measure Information:
Title
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
Description
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.
Time Frame
180-Day
Secondary Outcome Measure Information:
Title
Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
Description
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.
Time Frame
90-Day
Other Pre-specified Outcome Measures:
Title
Snap-Back Test Grade Analysis of Change from Baseline to Day 30
Description
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).
Time Frame
30-Day
Title
Snap-Back Test Grade Analysis of Change from Baseline to Day 90
Description
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).
Time Frame
90-Day
Title
Snap-Back Test Grade Analysis of Change from Baseline to Day 180
Description
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).
Time Frame
180-Day
Title
Medical Canthal Laxity Test Analysis of Change from Baseline to Day 30
Description
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).
Time Frame
30-Day
Title
Medical Canthal Laxity Test Analysis of Change from Baseline to Day 90
Description
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).
Time Frame
90-Day
Title
Medical Canthal Laxity Test Analysis of Change from Baseline to Day 180
Description
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).
Time Frame
180-Day
Title
Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 30
Description
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).
Time Frame
30-Day
Title
Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 90
Description
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).
Time Frame
90-Day
Title
Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 180
Description
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).
Time Frame
180-Day
Title
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
90-Day
Title
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
180-Day
Title
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
90-Day
Title
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
180-Day
Title
Day 180 Patient Satisfaction Questionnaire (PSQ)
Description
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.
Time Frame
180-Day
Title
Average Pain at Procedure Day Reported by Subject
Description
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"
Time Frame
Procedure Day 0
Title
Average Pain at Day 1 Reported by Subject
Description
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"
Time Frame
1-Day
Title
Average Pain at Day 3 Reported by Subject
Description
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"
Time Frame
3-Day
Title
Average Pain at Day 7 Reported by Subject
Description
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"
Time Frame
7-Day
Title
Average Pain at Day 30 Reported by Subject
Description
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"
Time Frame
30-Day
Title
Average Pain at Day 90 Reported by Subject
Description
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"
Time Frame
90-Day
Title
Average Pain at Day 180 Reported by Subject
Description
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"
Time Frame
180-Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aris Sterodimas, MD
Organizational Affiliation
Metropolitan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metropolitan General Hospital
City
Athens
ZIP/Postal Code
15562
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Post-Market Lower Eyelid Treatment With Renuvion in Greece
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