Trial Outcomes & Findings for Post Market Study Using The Elite IQ Device (NCT NCT04807205)
NCT ID: NCT04807205
Last Updated: 2024-06-12
Results Overview
Blind identification of pre-treatment images vs. 60 day follow up images. It is performed by independent reviewers. The outcome will be reported as a percentage of photographs identified correctly.
COMPLETED
NA
20 participants
60 day (+/- 30 days) post last treatment
2024-06-12
Participant Flow
Participant milestones
| Measure |
Elite IQ Laser
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Market Study Using The Elite IQ Device
Baseline characteristics by cohort
| Measure |
Elite IQ Laser
n=20 Participants
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
7 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
8 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
2 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
2 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 day (+/- 30 days) post last treatmentPopulation: Three subjects had an extra treatment area treated, and were graded for each separate treatment area, so the total number of treatment areas graded was 23 (23 photos were analyzed). Each photo was graded by 3 individual graders, for a total of 69 photos being analyzed. The average percentage of photographs identified correctly of these 3 graders is reported.
Blind identification of pre-treatment images vs. 60 day follow up images. It is performed by independent reviewers. The outcome will be reported as a percentage of photographs identified correctly.
Outcome measures
| Measure |
Elite IQ Laser
n=69 Photos
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up.
|
94.2 % of photos correctly identified
Standard Deviation .05
|
SECONDARY outcome
Timeframe: 60 day (+/- 30 days) post last treatmentPrinciple Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 60 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." This is the count of the number of subjects who the physician graded a 3 or higher.
Outcome measures
| Measure |
Elite IQ Laser
n=20 Participants
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS)
|
20 Participants
|
SECONDARY outcome
Timeframe: 60 day (+/- 30 days) post last treatmentSubject satisfaction rates at the 60 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. This is the count of the number of subjects who graded themselves a 4 or higher.
Outcome measures
| Measure |
Elite IQ Laser
n=20 Participants
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Subject Satisfaction
|
20 Participants
|
Adverse Events
Elite IQ Laser
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elite IQ Laser
n=20 participants at risk
The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms.
RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device
|
|---|---|
|
Skin and subcutaneous tissue disorders
Blistering
|
10.0%
2/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
|
Skin and subcutaneous tissue disorders
Crusting
|
20.0%
4/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
|
Skin and subcutaneous tissue disorders
Edema
|
100.0%
20/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
20/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.0%
1/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
5.0%
1/20 • All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER