Trial Outcomes & Findings for Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region (NCT NCT04146467)
NCT ID: NCT04146467
Last Updated: 2022-07-20
Results Overview
Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
180-Day
Results posted on
2022-07-20
Participant Flow
Participant milestones
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
|
Overall Study
STARTED
|
17
|
65
|
|
Overall Study
COMPLETED
|
17
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
Baseline characteristics by cohort
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=65 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Average Age
|
58.5 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Age, Customized
Median Age
|
59 years
n=5 Participants
|
57.0 years
n=7 Participants
|
57.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Greek Spanish
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
65 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.5 kg/m^2
n=5 Participants
|
24.7 kg/m^2
n=7 Participants
|
24.8 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 180-DayImprovement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=7 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
|
6 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Phase I: 17 total participants started Phase I. 4 participants missed their Day 7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 13 participants. Phase II: 65 participants started Phase 2. 1 participant exited the study prior to Day 7 follow-up visit. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 64 participants.
The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=13 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=64 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
|
Subject Reported Pain - None to Moderate
|
13 Participants
|
62 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayPopulation: Phase I: 17 total participants started Phase I. 7 participants missed their D90 images due to COVID-19 office closures and/or restrictions. Therefore, D90 Independent Photographic Review data was only available for 10 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Independent Photographic Review data was only available for 63 participants.
Change in the appearance of lax tissue in the neck and submental region at 90-days as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=10 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Day 90 Number of Participants With Improvement Measured By Independent Photographic Review
|
8 Participants
|
48 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayPopulation: Phase I: 17 total participants started Phase I. 1 participant missed their D90 Modified GAIS due to COVID-19 office closures and/or restrictions. Therefore, D90 Subject Modified GAIS data was only available for 16 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Subject Modified GAIS data was only available for 63 participants.
Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=16 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
|---|---|---|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
0 Participants
|
7 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
7 Participants
|
18 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
5 Participants
|
33 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
3 Participants
|
3 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
0 Participants
|
1 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
1 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayPopulation: Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=62 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
|---|---|---|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
4 Participants
|
12 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
5 Participants
|
17 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
3 Participants
|
24 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
3 Participants
|
7 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
1 Participants
|
2 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
0 Participants
|
|
Subject Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayPopulation: Phase I: 17 total participants started Phase I. 2 participants completed virtual visits and 1 participant missed their D90 visit due to COVID-19 office closures and/or restrictions. Therefore, D90 Investigator GAIS data was only available for 14 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 visit. Therefore, Day 90 Investigator GAIS data was only available for 63 participants.
Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=14 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
|---|---|---|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Very Much Improved
|
0 Participants
|
8 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Much Improved
|
3 Participants
|
19 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Improved
|
8 Participants
|
33 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
No Change
|
2 Participants
|
3 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Worse
|
1 Participants
|
0 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
0 Participants
|
|
Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayPopulation: Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=62 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
|---|---|---|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Improved
|
2 Participants
|
8 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Improved
|
6 Participants
|
19 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Improved
|
5 Participants
|
27 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
No Change
|
3 Participants
|
6 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Worse
|
1 Participants
|
2 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Much Worse
|
0 Participants
|
0 Participants
|
|
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Very Much Worse
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayPopulation: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit and 2 participants was lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Patient Satisfaction Questionnaire data was only available for 62 participants.
At 180 days post procedure, the subject's satisfaction with the procedure was assessed using a Patient Satisfaction Questionnaire. Questions were YES or NO questions pertaining to satisfaction with study treatment, observations of improvement, and considerations for recommendation.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=62 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
|---|---|---|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Happy With Results of Procedure
|
12 Participants
|
47 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to More Jawline Definition
|
NA Participants
Data not collected in Study Phase I
|
39 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Reduction in Jowls
|
NA Participants
Data not collected in Study Phase I
|
20 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Improvement in Skin Texture in Treatment Area
|
NA Participants
Data not collected in Study Phase I
|
20 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Reduction in the Area Under the Chin
|
NA Participants
Data not collected in Study Phase I
|
41 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Reduction of Lines & Wrinkles in the Treatment Area
|
NA Participants
Data not collected in Study Phase I
|
21 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Other Changes
|
NA Participants
Data not collected in Study Phase I
|
10 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Would Recommend Procedure to a Friend
|
12 Participants
|
46 Participants
|
|
Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Number of Subjects that Answered YES to Would Consider Having the Procedure on Another Body Area
|
11 Participants
|
47 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayPopulation: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 1 participant completed a virtual visit, and 2 participants were lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Quantitative Improvement data was only available for 61 participants.
Quantitative improvement in overall lift of the neck and submental area as determine by quantitative assessment based on 2D photography with Canfield Vectra system analysis. Fixed landmarks on the subject's face were used.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=61 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Quantitative Improvement in Overall Lift of the Neck and Submental Area
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—
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38 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayPopulation: Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 2 participants were lost to follow-up prior to D180 visit, 1 participant completed a virtual visit for D180 and did not have photographs for volume assessment, and 1 subject had poor image quality that resulted in the inability to assess volume change. Therefore, Day 180 Quantitative Improvement in Submental Volume was only available for 60 participants.
Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis.
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=60 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Quantitative Improvement in Submental Volume
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—
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41 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 7-DayPopulation: Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Average Pain data was only available for 13 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Average Pain data was only available for 64 participants.
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=13 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=64 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Average Pain at Day 7 Reported by Subject
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1.23 score on a scale
Standard Deviation 1.24
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0.6 score on a scale
Standard Deviation 1.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: 7-DayPopulation: Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Median Pain data was only available for 13 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Median Pain data was only available for 64 participants.
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=13 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=64 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Median Pain Reported by Subject at Day 7
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1.0 score on a scale
Interval 0.0 to 3.0
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0.0 score on a scale
Interval 0.0 to 1.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayPopulation: Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Average Pain data was only available for 15 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Average Pain data was only available for 63 participants.
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=15 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Average Pain Reported by Subject at Day 30
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1.33 score on a scale
Standard Deviation 2.66
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0.2 score on a scale
Standard Deviation 0.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayPopulation: Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Median Pain data was only available for 15 participants. Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Median Pain data was only available for 63 participants.
Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=15 Participants
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
|
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=63 Participants
All subjects treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Median Pain Reported by Subject at Day 30
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0 score on a scale
Interval 0.0 to 9.0
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0.0 score on a scale
Interval 0.0 to 0.0
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Adverse Events
Sub-Dermal Neck Renuvion APR Device - Study Phase II
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Sub-Dermal Neck Renuvion APR Device - Study Phase I
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=65 participants at risk
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 participants at risk
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Gastrointestinal disorders
Lower GI Bleed
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1.5%
1/65 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects
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0.00%
0/17 • Through 6 month follow-up visit for all enrolled subjects
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General disorders
Acute Appendicitis
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1.5%
1/65 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects
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0.00%
0/17 • Through 6 month follow-up visit for all enrolled subjects
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Renal and urinary disorders
Kidney Stone
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1.5%
1/65 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects
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0.00%
0/17 • Through 6 month follow-up visit for all enrolled subjects
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Other adverse events
| Measure |
Sub-Dermal Neck Renuvion APR Device - Study Phase II
n=65 participants at risk
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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Sub-Dermal Neck Renuvion APR Device - Study Phase I
n=17 participants at risk
All subjects will be treated with the Renuvion APR device.
Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Edema/Swelling
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92.3%
60/65 • Through 6 month follow-up visit for all enrolled subjects
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82.4%
14/17 • Through 6 month follow-up visit for all enrolled subjects
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Skin and subcutaneous tissue disorders
Temporary sensory nerve injury (loss of sensation)
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87.7%
57/65 • Through 6 month follow-up visit for all enrolled subjects
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29.4%
5/17 • Through 6 month follow-up visit for all enrolled subjects
|
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Skin and subcutaneous tissue disorders
Ecchymosis/ bruising
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55.4%
36/65 • Through 6 month follow-up visit for all enrolled subjects
|
58.8%
10/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Skin and subcutaneous tissue disorders
Erythema
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49.2%
32/65 • Through 6 month follow-up visit for all enrolled subjects
|
17.6%
3/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Skin and subcutaneous tissue disorders
Crepitus
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41.5%
27/65 • Through 6 month follow-up visit for all enrolled subjects
|
17.6%
3/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Skin and subcutaneous tissue disorders
Pain/tenderness
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24.6%
16/65 • Through 6 month follow-up visit for all enrolled subjects
|
29.4%
5/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Skin and subcutaneous tissue disorders
Nodules/subcutaneous lumps (migratory firmness)
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12.3%
8/65 • Through 6 month follow-up visit for all enrolled subjects
|
35.3%
6/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Nervous system disorders
Temporary motor nerve Injury (nerve weakness, muscle atrophy, twitching, and paralysis)
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6.2%
4/65 • Through 6 month follow-up visit for all enrolled subjects
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5.9%
1/17 • Through 6 month follow-up visit for all enrolled subjects
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching (not related to nerve injury)
|
6.2%
4/65 • Through 6 month follow-up visit for all enrolled subjects
|
0.00%
0/17 • Through 6 month follow-up visit for all enrolled subjects
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Additional Information
Kari Larson, MBA, Sr. Director, Clinical Affairs
Apyx Medical
Phone: 8012440058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER