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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renuvion APR System Treatment | Experimental | Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180-Day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Snap-Back Test Grade Analysis of Change From Baseline to Day 30 | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aris Sterodimas, MD | Metropolitan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan General Hospital | Athens | 15562 | Greece |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renuvion APR System Treatment | Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area. Renuvion APR System: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renuvion APR System Treatment | Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area. Renuvion APR System: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 180-Day |
|
Through Day 180 follow-up visit.
Adverse events and expected treatment effects (ETEs) were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Renuvion APR System Treatment | Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area. Renuvion APR System: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Larson, Sr. Director of Clinical Affairs | Apyx Medical | 8012440058 | kari.larson@apyxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2023 | Mar 24, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| 90-Day |
| 30-Day |
| Snap-Back Test Grade Analysis of Change From Baseline to Day 90 | 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). | 90-Day |
| Snap-Back Test Grade Analysis of Change From Baseline to Day 180 | 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). | 180-Day |
| Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30 | 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). | 30-Day |
| Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90 | 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). | 90-Day |
| Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180 | 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). | 180-Day |
| Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30 | 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). | 30-Day |
| Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90 | 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). | 90-Day |
| Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180 | 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). | 180-Day |
| Subject Modified Global Aesthetic Improvement Scale (GAIS) | 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. | 90-Day |
| Subject Modified Global Aesthetic Improvement Scale (GAIS) | 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. | 180-Day |
| Investigator Modified Global Aesthetic Improvement Scale (GAIS) | 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. | 90-Day |
| Investigator Modified Global Aesthetic Improvement Scale (GAIS) | 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. | 180-Day |
| Day 180 Patient Satisfaction Questionnaire (PSQ) | 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. | 180-Day |
| Average Pain at Procedure Day Reported by Subject | 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" | Procedure Day 0 Following Study Treatment (within 60 minutes post procedure) |
| Average Pain at Day 1 Reported by Subject | 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" | 1-Day |
| Average Pain at Day 3 Reported by Subject | 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" | 3-Day |
| Average Pain at Day 7 Reported by Subject | 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" | 7-Day |
| Average Pain at Day 30 Reported by Subject | 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" | 30-Day |
| Average Pain at Day 90 Reported by Subject | 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" | 90-Day |
| Average Pain at Day 180 Reported by Subject | 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" | 180-Day |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NRS for Pain | Count of Participants | Participants |
|
| Snap-Back Test Grade | 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. 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). | Count of Participants | Participants |
|
| Medial Canthal Laxity Test Grade | 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). | Count of Participants | Participants |
|
| Lateral Canthal Laxity Test Grade | 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). | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Snap-Back Test Grade Analysis of Change From Baseline to Day 30 | 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). | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Snap-Back Test Grade Analysis of Change From Baseline to Day 90 | 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). | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Snap-Back Test Grade Analysis of Change From Baseline to Day 180 | 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). | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30 | 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). | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90 | 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). | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180 | 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). | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30 | 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). | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90 | 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). | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180 | 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). | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Subject Modified Global Aesthetic Improvement Scale (GAIS) | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Subject Modified Global Aesthetic Improvement Scale (GAIS) | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Day 180 Patient Satisfaction Questionnaire (PSQ) | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Average Pain at Procedure Day Reported by Subject | 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" | Posted | Count of Participants | Participants | Procedure Day 0 Following Study Treatment (within 60 minutes post procedure) |
|
|
|
| Other Pre-specified | Average Pain at Day 1 Reported by Subject | 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" | Posted | Count of Participants | Participants | 1-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 3 Reported by Subject | 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" | Posted | Count of Participants | Participants | 3-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 7 Reported by Subject | 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" | Posted | Count of Participants | Participants | 7-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 30 Reported by Subject | 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" | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 90 Reported by Subject | 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" | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 180 Reported by Subject | 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" | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 14 |
| 16 |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Edema (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| Grade III |
|
| Grade IV |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No |
|
| Less Sagging Skin |
|
| Smoother Skin Texture |
|
| Level of Satisfaction (Very Satisfied, Satisfied, Slightly Satisfied) |
|
| Yes, would recommend to friends & family |
|
| 3 |
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