Trial Outcomes & Findings for Post-Market Lower Eyelid Treatment With Renuvion in Greece (NCT NCT05605691)
NCT ID: NCT05605691
Last Updated: 2025-03-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
180-Day
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Post-Market Lower Eyelid Treatment With Renuvion in Greece
Baseline characteristics by cohort
| Measure |
Renuvion APR System Treatment
n=16 Participants
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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|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
16 participants
n=5 Participants
|
|
NRS for Pain
0
|
16 Participants
n=5 Participants
|
|
NRS for Pain
1
|
0 Participants
n=5 Participants
|
|
NRS for Pain
2
|
0 Participants
n=5 Participants
|
|
NRS for Pain
3
|
0 Participants
n=5 Participants
|
|
NRS for Pain
4
|
0 Participants
n=5 Participants
|
|
NRS for Pain
5
|
0 Participants
n=5 Participants
|
|
NRS for Pain
6
|
0 Participants
n=5 Participants
|
|
NRS for Pain
7
|
0 Participants
n=5 Participants
|
|
NRS for Pain
8
|
0 Participants
n=5 Participants
|
|
NRS for Pain
9
|
0 Participants
n=5 Participants
|
|
NRS for Pain
10
|
0 Participants
n=5 Participants
|
|
Snap-Back Test Grade
Grade 0
|
0 Participants
n=5 Participants
|
|
Snap-Back Test Grade
Grade I
|
9 Participants
n=5 Participants
|
|
Snap-Back Test Grade
Grade II
|
3 Participants
n=5 Participants
|
|
Snap-Back Test Grade
Grade III
|
4 Participants
n=5 Participants
|
|
Snap-Back Test Grade
Grade IV
|
0 Participants
n=5 Participants
|
|
Medial Canthal Laxity Test Grade
Grade 0
|
1 Participants
n=5 Participants
|
|
Medial Canthal Laxity Test Grade
Grade I
|
14 Participants
n=5 Participants
|
|
Medial Canthal Laxity Test Grade
Grade II
|
1 Participants
n=5 Participants
|
|
Medial Canthal Laxity Test Grade
Grade III
|
0 Participants
n=5 Participants
|
|
Medial Canthal Laxity Test Grade
Grace IV
|
0 Participants
n=5 Participants
|
|
Lateral Canthal Laxity Test Grade
Grade 0
|
1 Participants
n=5 Participants
|
|
Lateral Canthal Laxity Test Grade
Grade I
|
14 Participants
n=5 Participants
|
|
Lateral Canthal Laxity Test Grade
Grade II
|
1 Participants
n=5 Participants
|
|
Lateral Canthal Laxity Test Grade
Grade III
|
0 Participants
n=5 Participants
|
|
Lateral Canthal Laxity Test Grade
Grade IV
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180-DayImprovement 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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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|---|---|
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Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
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5 Participants
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SECONDARY outcome
Timeframe: 90-DayImprovement 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
|
8 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
Grade II
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
Grade III
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
Grade IV
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
Grade 0
|
15 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
Grade I
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
Grade 0
|
15 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
Grade I
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
Grade II
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
Grade III
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
Grade 0
|
15 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
Grade I
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
Grade II
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
Grade III
|
0 Participants
|
|
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade 0
|
13 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade I
|
2 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade II
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade III
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade 0
|
15 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade I
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade II
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade III
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade 0
|
15 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade I
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade II
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade III
|
0 Participants
|
|
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade 0
|
13 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade I
|
2 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade II
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade III
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade 0
|
15 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade I
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade II
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade III
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThis 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).
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade 0
|
15 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade I
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade II
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade III
|
0 Participants
|
|
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
Grade IV
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThe 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
14 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
1 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThe 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
10 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
5 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThe 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
15 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThe 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
14 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
1 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayAt 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.
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Improvement Noticed · Yes
|
15 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Improvement Noticed · No
|
0 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Improvement in Wrinkles · Yes
|
7 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Improvement in Wrinkles · No
|
8 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Less Sagging Skin · Yes
|
12 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Less Sagging Skin · No
|
3 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Smoother Skin Texture · Yes
|
11 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Smoother Skin Texture · No
|
4 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Level of Satisfaction (Very Satisfied, Satisfied, Slightly Satisfied) · Yes
|
15 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Level of Satisfaction (Very Satisfied, Satisfied, Slightly Satisfied) · No
|
0 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Yes, would recommend to friends & family · Yes
|
15 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ)
Yes, would recommend to friends & family · No
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=16 Participants
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.
|
|---|---|
|
Average Pain at Procedure Day Reported by Subject
0
|
16 Participants
|
|
Average Pain at Procedure Day Reported by Subject
1
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
2
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
3
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
4
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
5
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
6
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
7
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
8
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
9
|
0 Participants
|
|
Average Pain at Procedure Day Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=16 Participants
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.
|
|---|---|
|
Average Pain at Day 1 Reported by Subject
0
|
16 Participants
|
|
Average Pain at Day 1 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 1 Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=16 Participants
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.
|
|---|---|
|
Average Pain at Day 3 Reported by Subject
0
|
16 Participants
|
|
Average Pain at Day 3 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 3 Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=16 Participants
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.
|
|---|---|
|
Average Pain at Day 7 Reported by Subject
0
|
16 Participants
|
|
Average Pain at Day 7 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 7 Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Average Pain at Day 30 Reported by Subject
0
|
15 Participants
|
|
Average Pain at Day 30 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 30 Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Average Pain at Day 90 Reported by Subject
0
|
15 Participants
|
|
Average Pain at Day 90 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 90 Reported by Subject
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayStudy 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"
Outcome measures
| Measure |
Renuvion APR System Treatment
n=15 Participants
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.
|
|---|---|
|
Average Pain at Day 180 Reported by Subject
0
|
15 Participants
|
|
Average Pain at Day 180 Reported by Subject
1
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
2
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
3
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
4
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
5
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
6
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
7
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
8
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
9
|
0 Participants
|
|
Average Pain at Day 180 Reported by Subject
10
|
0 Participants
|
Adverse Events
Renuvion APR System Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Renuvion APR System Treatment
n=16 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruise (ETE)
|
87.5%
14/16 • Number of events 14 • Through Day 180 follow-up visit.
Adverse events and expected treatment effects (ETEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
6.2%
1/16 • Number of events 1 • Through Day 180 follow-up visit.
Adverse events and expected treatment effects (ETEs) were collected.
|
|
Skin and subcutaneous tissue disorders
Edema (ETE)
|
81.2%
13/16 • Number of events 13 • Through Day 180 follow-up visit.
Adverse events and expected treatment effects (ETEs) were collected.
|
Additional Information
Kari Larson, Sr. Director of Clinical Affairs
Apyx Medical
Phone: 8012440058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place