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This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device.
Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure.
Phase II (n=65) of this study is the expansion of the study to a pivotal study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Phase I | Experimental | Subjects will be treated with the Renuvion APR device in the neck and submental region. |
|
| Study Phase II | Experimental | Subjects will be treated with the Renuvion APR device in the neck and submental region. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | 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. | 180-Day |
| Subject Reported Pain - None to Moderate | 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%. | Day 7 |
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| Measure | Description | Time Frame |
|---|---|---|
| Day 90 Number of Participants With Improvement Measured By Independent Photographic Review | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul G Ruff IV, MD | West End Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faces+ Plastic Surgery | San Diego | California | 92121 | United States | ||
| West End Plastic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | 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. | Posted | Count of Participants | Participants | 180-Day |
|
Through 6 month follow-up visit for all enrolled subjects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower GI Bleed | Gastrointestinal disorders | Non-systematic Assessment | Not related to device or procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema/Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
Limitations of this study was the pandemic that occurred in the middle of the study and caused study visits to be more challenging for all subjects enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Larson, MBA, Sr. Director, Clinical Affairs | Apyx Medical | 8012440058 | kari.larson@apyxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2020 | Apr 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2020 | Apr 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| 90-Day |
| Subject Modified Global Aesthetic Improvement Scale (GAIS) | Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 90-Day |
| Subject Modified Global Aesthetic Improvement Scale (GAIS) | Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 180-Day |
| Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 90-Day |
| Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 180-Day |
| Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | 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. | 180-Day |
| Quantitative Improvement in Overall Lift of the Neck and Submental Area | 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. | 180-Day |
| Quantitative Improvement in Submental Volume | Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis. | 180-Day |
| Average Pain at Day 7 Reported by Subject | 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" | 7-Day |
| Median Pain Reported by Subject at Day 7 | 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" | 7-Day |
| Average Pain Reported by Subject at Day 30 | 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" | 30-Day |
| Median Pain Reported by Subject at Day 30 | 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" | 30-Day |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| New Jersey Clinical Research Center | Montclair | New Jersey | 07042 | United States |
| Luxurgery | New York | New York | 10021 | United States |
| H/K/B Cosmetic Surgery | Huntersville | North Carolina | 28078 | United States |
| Facial Plastic & Aesthetic Laser Center | Youngstown | Ohio | 44512 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| OG001 | Sub-Dermal Neck Renuvion APR Device - Study Phase II | 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. |
|
|
|
| Primary | Subject Reported Pain - None to Moderate | 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%. | 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. | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Other Pre-specified | Day 90 Number of Participants With Improvement Measured By Independent Photographic Review | 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. | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
|
| Other Pre-specified | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Subject Modified Global Aesthetic Improvement Scale (GAIS) | Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 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 | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Investigator Modified Global Aesthetics Improvement Scale (GAIS) | Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Investigator Modified Global Aesthetic Improvement Scale (GAIS) | Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | 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 | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure | 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. | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Quantitative Improvement in Overall Lift of the Neck and Submental Area | 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. | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Quantitative Improvement in Submental Volume | Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis. | 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. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Average Pain at Day 7 Reported by Subject | 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" | 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. | Posted | Mean | Standard Deviation | score on a scale | 7-Day |
|
|
|
|
| Other Pre-specified | Median Pain Reported by Subject at Day 7 | 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" | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 7-Day |
|
|
|
| Other Pre-specified | Average Pain Reported by Subject at Day 30 | 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" | 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. | Posted | Mean | Standard Deviation | score on a scale | 30-Day |
|
|
|
| Other Pre-specified | Median Pain Reported by Subject at Day 30 | 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" | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 30-Day |
|
|
|
| 0 |
| 65 |
| 3 |
| 65 |
| 62 |
| 65 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 16 | 17 |
|
| Acute Appendicitis | General disorders | Non-systematic Assessment | Not related to device or procedure. |
|
| Kidney Stone | Renal and urinary disorders | Non-systematic Assessment | Not related to device or procedure. |
|
|
| Temporary sensory nerve injury (loss of sensation) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Ecchymosis/ bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Crepitus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Pain/tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Nodules/subcutaneous lumps (migratory firmness) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected Treatment Effect |
|
| Temporary motor nerve Injury (nerve weakness, muscle atrophy, twitching, and paralysis) | Nervous system disorders | Non-systematic Assessment |
|
| Pruritus/itching (not related to nerve injury) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Number of Subjects that Answered YES to Reduction in Jowls |
|
| Number of Subjects that Answered YES to Improvement in Skin Texture in Treatment Area |
|
| Number of Subjects that Answered YES to Reduction in the Area Under the Chin |
|
| Number of Subjects that Answered YES to Reduction of Lines & Wrinkles in the Treatment Area |
|
| Number of Subjects that Answered YES to Other Changes |
|
| Number of Subjects that Answered YES to Would Recommend Procedure to a Friend |
|
| Number of Subjects that Answered YES to Would Consider Having the Procedure on Another Body Area |
|