Clinical trial NCT05605691: 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
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Periorbital
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
timeFrame: 180-Day
Secondary outcomes:
measure: Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
timeFrame: 90-Day
Other outcomes:
measure: Snap-Back Test Grade Analysis of Change From Baseline to Day 30
timeFrame: 30-Day
measure: Snap-Back Test Grade Analysis of Change From Baseline to Day 90
timeFrame: 90-Day
measure: Snap-Back Test Grade Analysis of Change From Baseline to Day 180
timeFrame: 180-Day
measure: Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
timeFrame: 30-Day
measure: Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
timeFrame: 90-Day
measure: Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
timeFrame: 180-Day
measure: Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
timeFrame: 30-Day
measure: Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
timeFrame: 90-Day
measure: Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
timeFrame: 180-Day
measure: Subject Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 90-Day
measure: Subject Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 180-Day
measure: Investigator Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 90-Day
measure: Investigator Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 180-Day
measure: Day 180 Patient Satisfaction Questionnaire (PSQ)
timeFrame: 180-Day
measure: Average Pain at Procedure Day Reported by Subject
timeFrame: Procedure Day 0 Following Study Treatment (within 60 minutes post procedure)
measure: Average Pain at Day 1 Reported by Subject
timeFrame: 1-Day
measure: Average Pain at Day 3 Reported by Subject
timeFrame: 3-Day
measure: Average Pain at Day 7 Reported by Subject
timeFrame: 7-Day
measure: Average Pain at Day 30 Reported by Subject
timeFrame: 30-Day
measure: Average Pain at Day 90 Reported by Subject
timeFrame: 90-Day
measure: Average Pain at Day 180 Reported by Subject
timeFrame: 180-Day
Locations:
city: Athens
country: Greece
facility: Metropolitan General Hospital
Study officials:
affiliation: Metropolitan General Hospital
name: Aris Sterodimas, MD
role: PRINCIPAL_INVESTIGATOR
References: