Facial Wrinkles, Rhytides
Conditions
Keywords
Rhytides, Wrinkle Reduction, J-Plasma, Dermal Resurfacing
Brief summary
This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.
Detailed description
The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use in dermal skin resurfacing. This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5 investigational centers in the United States. Study subjects that meet study eligibility criteria and have provided informed consent will be enrolled in the study. During the procedure, the investigators will use J-Plasma on applicable facial zones to reduce wrinkles and rhytides. Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6 months post-procedure for study assessments. Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will continue through 6 months post-procedure. Total study duration is expected to be approximately 9-12 months. Primary study endpoints will be assessed at 3 months following the procedure.
Interventions
DEVICEJ-Plasma
Dermal resurfacing procedure with J-Plasma.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a single-arm study in which investigators are not blinded. However, blinded Independent Photographic Reviewers (IPR) will be utilized to review all images (baseline and all follow-up time points) and assign FWS scores.
Intervention model description
This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. Enrolled study subjects will receive one procedure with J-Plasma at enrollment. Wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. Scores at each follow-up time point will be compared to the scores at baseline for each enrolled subject.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects ≥30 years of age. 2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides. 3. Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by the investigator. 4. Subject with a Fitzpatrick Skin Scale score ≤III. 5. Subject is willing and able to provide written informed consent. 6. Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits. 7. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication. 8. Subject is willing to abstain from other facial cosmetic procedures through the 6 month follow-up visit; examples include, but are not limited to, laser or chemical re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
Exclusion criteria
1. Subject with a Fitzpatrick Skin Scale score \>III. 2. Subject is pregnant or lactating. 3. Active HSV-1 or diabetes mellitus. 4. Active cut, wound, or infection on the skin of the face. 5. Subject has used, within the past 30 days, Accutane or any medication that can cause dermal hypersensitivity. 6. Subject has a history of autoimmune disease. 7. Subject with a bleeding disorder or who is on blood thinning medication that may be at risk for bleeding. 8. Subject has a known adverse reaction to anesthetics. 9. Subjects with active skin disease of the facial area or known connective tissue disease. 10. Subjects with known susceptibility to keloid formation or hypertrophic scarring. 11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated. 12. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s); 13. Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and efficacy of the study treatment method. 14. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication. 15. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments. 16. Subject has undergone a facelift procedure or received facial injections within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score | Baseline to 3 months | The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. |
| Adverse Event Rate and Duration | Up to 3 months | Adverse event rates, categorized by duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an Improved Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit. | Baseline to 3 months | Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved. |
| Evaluation of Pain and Discomfort | Baseline to 3 months | The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Re-epithelialization - 1 Month | 1 Month | Achievement of re-epithelialization by facial zone and across facial zones after treatment |
| Achievement of Re-epithelialization - 3 Months | 3 Months | Achievement of re-epithelialization by facial zone and across facial zones after treatment |
| Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months | Baseline to 3 months | Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an improved rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved. |
| Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days | Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days). |
| Proportion of Subjects With Correct Identification of 3-month Images | Baseline to 3 months | The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. |
| Mean Duration for Study Subject to Feel Comfortable in Public After Treatment | Up to 3 months | Mean duration for study subject to feel comfortable in public after treatment as reported by the subject |
| Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit | Baseline to 3 months | Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement. |
| Study Subject Satisfaction at 3-month Visit | 3 Months | Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction |
| Achievement of Re-epithelialization - 10 Days | 10 Days | Achievement of re-epithelialization by facial zone and across facial zones after treatment |
Countries
United States
Participant flow
Pre-assignment details
All participants who were enrolled were assigned to a/the treatment group.
Participants by arm
| Arm | Count |
|---|---|
| J-Plasma Each study subject received one procedure with J-Plasma at enrollment.
J-Plasma: Dermal resurfacing procedure with J-Plasma. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | J-Plasma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 61.5 years |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 1 | 1 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 2 | 2 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 3 | 1 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 4 | 10 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 5 | 4 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 6 | 1 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 7 | 8 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 8 | 20 Participants |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 9 | 8 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants |
| Race/Ethnicity, Customized White | 48 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 39 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Adverse Event Rate and Duration
Adverse event rates, categorized by duration
Time frame: Up to 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| J-Plasma | Adverse Event Rate and Duration | Percentage of Serious Adverse Events | 0 percentage of adverse events |
| J-Plasma | Adverse Event Rate and Duration | Percentage of Adverse Events Resolved in 7 Days | 41.8 percentage of adverse events |
| J-Plasma | Adverse Event Rate and Duration | Percentage Adverse Events Resolved in 14 Days | 58 percentage of adverse events |
Primary
Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.
Time frame: Baseline to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| J-Plasma | Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score | 51 Participants |
Secondary
Evaluation of Pain and Discomfort
The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Evaluation of Pain and Discomfort | -3.8 score on a scale | Standard Deviation 3 |
Secondary
Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an Improved Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.
Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved.
Time frame: Baseline to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| J-Plasma | Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an Improved Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit. | 53 Participants |
Other Pre-specified
Achievement of Re-epithelialization - 10 Days
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 10 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Achievement of Re-epithelialization - 10 Days | 96.8 percentage of re-epithelialization | Standard Deviation 5.7 |
Other Pre-specified
Achievement of Re-epithelialization - 1 Month
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Achievement of Re-epithelialization - 1 Month | 100 percentage of re-epithelialization | Standard Deviation 0 |
Other Pre-specified
Achievement of Re-epithelialization - 3 Months
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 3 Months
Population: Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months.
Other Pre-specified
Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit
Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit | -2.13 units on a scale | Standard Deviation 1.02 |
Other Pre-specified
Mean Duration for Study Subject to Feel Comfortable in Public After Treatment
Mean duration for study subject to feel comfortable in public after treatment as reported by the subject
Time frame: Up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Mean Duration for Study Subject to Feel Comfortable in Public After Treatment | 8.5 days | Standard Deviation 2.5 |
Other Pre-specified
Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months
Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an improved rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved.
Time frame: Baseline to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| J-Plasma | Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months | 50 Participants |
Other Pre-specified
Proportion of Subjects With Correct Identification of 3-month Images
The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.
Time frame: Baseline to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| J-Plasma | Proportion of Subjects With Correct Identification of 3-month Images | 54 Participants |
Other Pre-specified
Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)
Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).
Time frame: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
Population: Pain scores on the Visual Analog Scale (VAS) were recorded on a daily diary and analyzed out to the 10 day follow-up visit, with a visit window of 9-14 days. Not all participants recorded a VAS score for each day on the daily diary. Participants' diaries were collected at their 10 day follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Pre-procedure 10-point Visual Analog Scale (VAS) | 0.1 score on a scale | Standard Deviation 0.4 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Immediately Post-Procedure 10-point Visual Analog | 4.3 score on a scale | Standard Deviation 2.6 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 0 10-point Visual Analog Scale (VAS) | 3.7 score on a scale | Standard Deviation 3.2 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 1 10-point Visual Analog Scale (VAS) | 2.6 score on a scale | Standard Deviation 2.6 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 2 10-point Visual Analog Scale (VAS) | 2.9 score on a scale | Standard Deviation 2.4 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 3 10-point Visual Analog Scale (VAS) | 2.7 score on a scale | Standard Deviation 2.2 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 4 10-point Visual Analog Scale (VAS) | 3.1 score on a scale | Standard Deviation 2.5 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 5 10-point Visual Analog Scale (VAS) | 3.1 score on a scale | Standard Deviation 2.6 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 6 10-point Visual Analog Scale (VAS) | 2.8 score on a scale | Standard Deviation 2.6 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 7 10-point Visual Analog Scale (VAS) | 2.4 score on a scale | Standard Deviation 2.2 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 8 10-point Visual Analog Scale (VAS) | 2.1 score on a scale | Standard Deviation 2.2 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 9 10-point Visual Analog Scale (VAS) | 1.9 score on a scale | Standard Deviation 2.3 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 10 10-point Visual Analog Scale (VAS) | 1.6 score on a scale | Standard Deviation 2.4 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 11 10-point Visual Analog Scale (VAS) | 1.6 score on a scale | Standard Deviation 2.5 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 12 10-point Visual Analog Scale (VAS) | 1.4 score on a scale | Standard Deviation 2.7 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 13 10-point Visual Analog Scale (VAS) | 1.3 score on a scale | Standard Deviation 2.5 |
| J-Plasma | Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days) | Day 14 10-point Visual Analog Scale (VAS) | 1.8 score on a scale | Standard Deviation 3.6 |
Other Pre-specified
Study Subject Satisfaction at 3-month Visit
Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| J-Plasma | Study Subject Satisfaction at 3-month Visit | 2.5 score on a scale | Standard Deviation 3 |