Trial Outcomes & Findings for Renuvion Dermal System for Dermal Resurfacing (NCT NCT04185909)
NCT ID: NCT04185909
Last Updated: 2022-06-22
Results Overview
The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
90-day
Results posted on
2022-06-22
Participant Flow
Participant milestones
| Measure |
Full-face Renuvion Dermal System Treatment
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Full-face Renuvion Dermal System Treatment
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Renuvion Dermal System for Dermal Resurfacing
Baseline characteristics by cohort
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Age, Customized
Adults 30 yrs of age or older who signed informed consent and who met inclusion/exclusion criteria.
|
65.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.3 kg/m^2
n=5 Participants
|
|
Fitzpatrick Skin Type Scale (FST)
Type I
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type Scale (FST)
Type II
|
38 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type Scale (FST)
Type III
|
13 Participants
n=5 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Class II: Score 5
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Class II: Score 6
|
14 Participants
n=5 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Class III: Score 7
|
12 Participants
n=5 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Class III: Score 8
|
19 Participants
n=5 Participants
|
|
Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Class III: Score 9
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90-dayThe FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
|
55 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-dayAt least 2 out of 3 blinded Independent Photographic Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of baseline and 90-day images.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Independent Photographic Reviewer Masked Assessment
|
55 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 90-day Change, 180-day ChangeMagnitude of improvement measured by the mean change in FWS from baseline, 90-day, 180-day visit as determined by Investigators. Scale ranges from 1 (no wrinkles) to 9 (most wrinkles).
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Investigator Fitzpatrick Wrinkle and Elastosis Scale
Baseline
|
7.4 score on a scale
Standard Deviation 1.1
|
|
Investigator Fitzpatrick Wrinkle and Elastosis Scale
90 Day Change
|
-4.4 score on a scale
Standard Deviation 1.8
|
|
Investigator Fitzpatrick Wrinkle and Elastosis Scale
180 Day Change
|
-4.4 score on a scale
Standard Deviation 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-daySubject rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Subject Global Aesthetic Improvement Scale
Very Much Improved
|
27 Participants
|
|
Subject Global Aesthetic Improvement Scale
Much Improved
|
21 Participants
|
|
Subject Global Aesthetic Improvement Scale
Improved
|
5 Participants
|
|
Subject Global Aesthetic Improvement Scale
No Change
|
2 Participants
|
|
Subject Global Aesthetic Improvement Scale
Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale
Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-dayInvestigator rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Investigator Global Aesthetic Improvement Scale
Very Much Improved
|
36 Participants
|
|
Investigator Global Aesthetic Improvement Scale
Much Improved
|
17 Participants
|
|
Investigator Global Aesthetic Improvement Scale
Improved
|
2 Participants
|
|
Investigator Global Aesthetic Improvement Scale
Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale
Much Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-day5 questions pertaining to satisfaction with results, would you recommend to a friend, would you have the procedure done again, any changes noticed, and any improvement in quality of life.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Patient Satisfaction Questionnaire
Happy With Results of Procedure
|
53 Participants
|
|
Patient Satisfaction Questionnaire
Would Recommend Procedure to a Friend
|
46 Participants
|
|
Patient Satisfaction Questionnaire
Would Consider Having the Procedure Performed Again
|
35 Participants
|
|
Patient Satisfaction Questionnaire
Which Changes do You See in the Area Treated: None
|
0 Participants
|
|
Patient Satisfaction Questionnaire
Skin Texture Improvement
|
52 Participants
|
|
Patient Satisfaction Questionnaire
Skin Tone Improvement
|
47 Participants
|
|
Patient Satisfaction Questionnaire
Skin Pigmentation Improvement
|
36 Participants
|
|
Patient Satisfaction Questionnaire
Fine Lines and Wrinkles Improvement
|
50 Participants
|
|
Patient Satisfaction Questionnaire
Skin Pore Size Improvement
|
40 Participants
|
|
Patient Satisfaction Questionnaire
Skin Feels Better
|
44 Participants
|
|
Patient Satisfaction Questionnaire
Skin Feels Tighter
|
51 Participants
|
|
Patient Satisfaction Questionnaire
Skin Looks Tighter
|
52 Participants
|
|
Patient Satisfaction Questionnaire
Skin Looks More Radiant
|
41 Participants
|
|
Patient Satisfaction Questionnaire
Skin Appears Brighter
|
38 Participants
|
|
Patient Satisfaction Questionnaire
Skin Seems More Youthful
|
50 Participants
|
|
Patient Satisfaction Questionnaire
Other Changes Noted
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 10Evaluation of the change in pain and discomfort after treatment (baseline, within 60 minutes following the procedure) as reported by the subject on a visual analog scale (VAS)experienced in the period up to the 10-day follow-up visit. Any pain or discomfort will be recorded daily by each participant in a diary using an 11-point Visual Analogue Scale (VAS) where 0 is no pain and 10 is most pain.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Pain and Discomfort
Baseline
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Pain and Discomfort
Post-Procedure
|
3.7 score on a scale
Standard Deviation 2.8
|
|
Pain and Discomfort
1 Day
|
2.4 score on a scale
Standard Deviation 2.6
|
|
Pain and Discomfort
6 Day
|
2.9 score on a scale
Standard Deviation 2.6
|
|
Pain and Discomfort
10 Day
|
1.1 score on a scale
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-day, 30-day, 90-dayAchievement of re-epithelialization by facial zone and across all facial zones as reported by the investigator.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Percentage of Subjects With Achievement of Re-Epithelialization
10 Day
|
3 Participants
|
|
Percentage of Subjects With Achievement of Re-Epithelialization
30 Day
|
48 Participants
|
|
Percentage of Subjects With Achievement of Re-Epithelialization
90 Day
|
55 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-dayMean duration until study subject feels comfortable going in public after treatment as reported by the study subject. Willing to go out in public by the 10-day visit.
Outcome measures
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 Participants
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Comfortable in Public
|
28 Participants
|
Adverse Events
Full-face Renuvion Dermal System Treatment
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 participants at risk
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Gastrointestinal disorders
Bowel Obstruction
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
Other adverse events
| Measure |
Full-face Renuvion Dermal System Treatment
n=55 participants at risk
Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Milia/acne
|
29.1%
16/55 • Number of events 20 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching (Expected Treatment Effect)
|
25.5%
14/55 • Number of events 14 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scarring
|
14.5%
8/55 • Number of events 8 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Post-inflammatory hyperpigmentation (Expected Treatment Effect)
|
10.9%
6/55 • Number of events 6 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Telangiectasias
|
10.9%
6/55 • Number of events 6 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Discoloration/hypopigmentation
|
5.5%
3/55 • Number of events 3 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Pinpoint Bleeding (Expected Treatment Effect)
|
3.6%
2/55 • Number of events 2 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Prolonged Wound Healing
|
3.6%
2/55 • Number of events 2 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Erythema/skin inflammation/ focal skin congestion (Expected Treatment Effect)
|
100.0%
55/55 • Number of events 56 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Crusting (Expected Treatment Effect)
|
100.0%
55/55 • Number of events 55 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Edema/Swelling (Expected Treatment Effect)
|
100.0%
55/55 • Number of events 55 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness (Expected Treatment Effect)
|
54.5%
30/55 • Number of events 30 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Urticaria/rash (Expected Treatment Effect)
|
3.6%
2/55 • Number of events 2 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Eye disorders
Eye Irritation
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Gastrointestinal disorders
Nausea during Procedure
|
5.5%
3/55 • Number of events 3 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Gastrointestinal disorders
Emesis/Vomiting Post-Procedure
|
3.6%
2/55 • Number of events 2 • Through 6 month follow-up visit for all enrolled subjects.
|
|
General disorders
Drug Reaction During Procedure
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Eye disorders
Lower Lid Retraction
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
|
Skin and subcutaneous tissue disorders
Self-Inflicted Superficial Excoriations
|
1.8%
1/55 • Number of events 1 • Through 6 month follow-up visit for all enrolled subjects.
|
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