Trial Outcomes & Findings for Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck (NCT NCT03803059)
NCT ID: NCT03803059
Last Updated: 2021-12-01
Results Overview
Wrinkling in the neck region will be assessed according to the following definitions: Class 0: No Wrinkles Class 1: Just perceptible wrinkle Class 2: Shallow wrinkles Class 3: Moderately deep wrinkle Class 4: Deep wrinkle, well-defined edges Class 5: Very deep wrinkle, redundant fold
COMPLETED
NA
35 participants
Day 1 and 3 Month Post Treatment
2021-12-01
Participant Flow
Pre-screening was conducted by phone to determine eligibility criteria through an IRB-approved script. Followed by in-clinic screening visits conducted between
Only participants who met eligibility requirements were enrolled into the study. The subjects were given Pre-study instructions that include wash out Period: No topical medications or topical retinoids 2 weeks prior to visit 1.
Participant milestones
| Measure |
Skinpen Precision System
Microneedle treatment to neck areas using SkinPen Precision system which includes: Surgical instrument motors and accessories/attachments/Hydrogel
A total of 32 subjects completed study participation.
At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.
On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's fine lines and wrinkles, on the neck with SkinPen Precision System at depths of up to 2.5mm. Each subject's treatment depth was recorded. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
During the treatment period (days 1-90), subjects used the supporting materials\[SKINFUSE® Purify Cleansing Complex, Reclaim Hydrating Support (Moisturizer), and Shield Zinc Oxide Sunscreen\] as directed.
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|---|---|
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Overall Study
STARTED
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35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Skinpen Precision System
Microneedle treatment to neck areas using SkinPen Precision system which includes: Surgical instrument motors and accessories/attachments/Hydrogel
A total of 32 subjects completed study participation.
At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.
On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's fine lines and wrinkles, on the neck with SkinPen Precision System at depths of up to 2.5mm. Each subject's treatment depth was recorded. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
During the treatment period (days 1-90), subjects used the supporting materials\[SKINFUSE® Purify Cleansing Complex, Reclaim Hydrating Support (Moisturizer), and Shield Zinc Oxide Sunscreen\] as directed.
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|---|---|
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Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
Baseline characteristics by cohort
| Measure |
SkinPen Precision System
n=35 Participants
Microneedle treatment to neck areas using SkinPen Precision system: Surgical instrument motors and accessories/attachments/Hydrogel.
At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.
On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's fine lines and wrinkles, on the neck with SkinPen Precision System at depths of up to 2.5mm. Each subject's treatment depth was recorded. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
During the treatment period (days 1-90), subjects used the supporting materials\[SKINFUSE® Purify Cleansing Complex, Reclaim Hydrating Support (Moisturizer), and Shield Zinc Oxide Sunscreen\] as directed.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
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33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Fitzpatrick Skin Classification
l
|
0 participants
n=93 Participants
|
|
Fitzpatrick Skin Classification
ll
|
25 participants
n=93 Participants
|
|
Fitzpatrick Skin Classification
lll
|
5 participants
n=93 Participants
|
|
Fitzpatrick Skin Classification
lV
|
5 participants
n=93 Participants
|
|
Fitzpatrick Skin Classification
V
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 1 and 3 Month Post TreatmentPopulation: Analysis population includes all participants completing the study.
Wrinkling in the neck region will be assessed according to the following definitions: Class 0: No Wrinkles Class 1: Just perceptible wrinkle Class 2: Shallow wrinkles Class 3: Moderately deep wrinkle Class 4: Deep wrinkle, well-defined edges Class 5: Very deep wrinkle, redundant fold
Outcome measures
| Measure |
Skinpen Precision System
n=32 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale
Day 1
|
3.31 Score on a Scale
Standard Deviation 0.74
|
|
Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale
3 Month Post Treatment
|
2.45 Score on a Scale
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: 3 Month Post TreatmentPopulation: The analysis population includes all participants completing the study.
This scale is completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the neck, and * Based on a comparison of the subject's pre-treatment photographs to the current post-treatment photographs of the neck. Rating and its Description 1 --Very Much Improved: Optimal cosmetic result in this subject. 2--Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3-Improved: Obvious improvement in appearance from the initial condition, but re-treatment is indicated. 4--No Change: The appearance is essentially the same as the original condition. 5--Worse: The appearance is worse than the original condition.
Outcome measures
| Measure |
Skinpen Precision System
n=32 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Clinician's Global Aesthetic Improvement Assessment (CGAIS)
|
3.06 Score on a Scale
Standard Deviation 0.74
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SECONDARY outcome
Timeframe: 1 Month Post Treatment and 3 Month Post TreatmentPopulation: Analysis Population includes all participants completing the study.
Rating and Description 1. -Very Much Improved: Optimal cosmetic result. 2. -Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal. 3. -Improved: Obvious improvement in appearance from the initial condition. 4. -No Change: The appearance is essentially the same as the original condition. 5. -Worse: The appearance is worse than the original condition
Outcome measures
| Measure |
Skinpen Precision System
n=32 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Subject Global Aesthetic Improvement Scale (SGAIS)
1 Month Post Treatment
|
2.90 score on a scale
Standard Deviation 0.84
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|
Subject Global Aesthetic Improvement Scale (SGAIS)
3 Month Post Treatment
|
3.16 score on a scale
Standard Deviation 0.72
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SECONDARY outcome
Timeframe: Baseline, 3 Months post treatmentPopulation: Analysis population description includes all participants completing this test.
The severity of wrinkles is more due to increased UV exposure through the driver's side window on the left side of the face and neck, due to this reason, the Principal investigator performed the TEWL on the left side of the neck. This test was pre-specified in the protocol. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. Biox Aquaflux is used to measure transepidermal water loss (TEWL) measurements which evaluate barrier function of the skin epidermal layer to determine the progress of epidermal healing after treatment. Day 1 will be used as a baseline to analyze the change from baseline. TEWL is measured in g/m2/h. Normal rates of TEWL - from 2.3 g/m2/h to 44 g/m2/h - are compromised due to injury, infection, and/or severe damage as in the case of burns A decrease inTEWL reflects less water loss and an improvement in the skin's barrier properties; an absence of a change in treate
Outcome measures
| Measure |
Skinpen Precision System
n=31 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Transepidermal Water Loss of the Left Neck by Biox Aquaflux
Baseline
|
15.56 g/m2/h
Standard Deviation 6.72
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Transepidermal Water Loss of the Left Neck by Biox Aquaflux
3 Month post treatment
|
14.62 g/m2/h
Standard Deviation 11.00
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SECONDARY outcome
Timeframe: Baseline (Day 1) and 3-Month post TreatmentPopulation: Analysis population includes everyone completing measurements art Baseline and 3 months post-treatment.
Vivosight, an Optical coherence tomography (OCT) device, is used to non-invasively gather topographical and histologic images of pre-and post-treated skin. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. OCT measurements of the vascular density are reported in percentage (%) and were performed on the neck at 100 microns, 200 microns, and 500 microns. Scores multiplied by 1000 for analysis. An increase in value indicates an increase in thickness and vascular density and skin tissue density.
Outcome measures
| Measure |
Skinpen Precision System
n=31 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC Measure at 100 microns- Day 1
|
27.66 % VD (Vascular Density)
Standard Deviation 19.76
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Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC measure at 100 microns- 3 Month post treatment
|
62.56 % VD (Vascular Density)
Standard Deviation 55.97
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|
Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC measure at 200 Microns- Day 1
|
74.45 % VD (Vascular Density)
Standard Deviation 39.36
|
|
Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC measure at 200 Microns- 3 month Post treatment
|
96.06 % VD (Vascular Density)
Standard Deviation 56.25
|
|
Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC measure at 500 Microns- Day 1
|
45.81 % VD (Vascular Density)
Standard Deviation 39.13
|
|
Vascular Density Measurements by Optical Coherence Tomography(OCT)
OTC measure at 500 Microns- 3 month Post treatment
|
36.07 % VD (Vascular Density)
Standard Deviation 40.91
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SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 Months post treatmentPopulation: The analysis population includes participants finishing this assessment at day 1 and 3 months post-treatment.
Vivosight, an optical coherence tomography (OCT) device, was used to noninvasively gather topographical and histologic images of pre-and post-treated skin. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. Roughness measurements were calculated from the histologic images using RA and RZ. Skin roughness is measured in micro-meters. Ra is the average roughness of a surface. Rz is the difference between the tallest "peak" and the deepest "valley" on the surface. A decrease in value indicates a decrease in skin roughness when Baseline and 3 months post-treatment are compared.
Outcome measures
| Measure |
Skinpen Precision System
n=25 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Skin Roughness Measurements by Optical Coherence Tomography(OCT)
RA-Day 1
|
0.03 micro-meters
Standard Error 0.04
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|
Skin Roughness Measurements by Optical Coherence Tomography(OCT)
RA-3 month post treatment
|
0.01 micro-meters
Standard Error 0.02
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|
Skin Roughness Measurements by Optical Coherence Tomography(OCT)
RZ-Day 1
|
0.11 micro-meters
Standard Error 0.03
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|
Skin Roughness Measurements by Optical Coherence Tomography(OCT)
RZ- 3 Month Post treatment
|
0.12 micro-meters
Standard Error 0.05
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SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 month post treatmentPopulation: Analysis population includes all participants completing this assessment on day 1 and 3 month post treatment.
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar) This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. BTC 2000 was used to measure energy absorption of the skin. The units for these measurements are Energy absorption - mmHg\*mm Decrease in values for energy absorption will be seen as Improvement
Outcome measures
| Measure |
Skinpen Precision System
n=29 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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BTC 2000 Measurements- Energy Absorption
Energy absorption-Day 1
|
105.78 mmHg*mm
Standard Deviation 59.96
|
|
BTC 2000 Measurements- Energy Absorption
Energy absorption- 3 Month post treatment
|
104.68 mmHg*mm
Standard Deviation 65.86
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 month post treatmentPopulation: Analysis population includes all participants completing this assessment on day 1 and 3 month post treatment.
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar) This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. BTC 2000 was used to measure Elasticity values of the skin. The units for these measurements are in % of the distance traveled in µm. A decrease case in values for elasticity will be seen as an improvement after the treatments.
Outcome measures
| Measure |
Skinpen Precision System
n=29 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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BTC 2000 Measurements for Skin Elasticity
Elasticity-Day 1
|
1.09 % of distance traveled in µm
Standard Deviation 0.60
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|
BTC 2000 Measurements for Skin Elasticity
Elasticity- 3 month post treatment
|
5.33 % of distance traveled in µm
Standard Deviation 10.90
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SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 month post treatmentPopulation: Analysis population includes all participants completing this assessment on day 1 and 3 month post treatment.
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar) This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. BTC 2000 was used to measure viscoelastic deformation, elastic deformation, and ultimate deformation values of the skin. The units for these measurements are in mm. A Decrease in values for these deformations will be seen as an Improvement.
Outcome measures
| Measure |
Skinpen Precision System
n=29 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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BTC 2000 Measurements for Skin Deformations
Viscoelastic Deformation- Day 1
|
0.15 mm
Standard Deviation 0.11
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BTC 2000 Measurements for Skin Deformations
Viscoelastic Deformation- 3 Month Post Treatment
|
0.16 mm
Standard Deviation 0.13
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BTC 2000 Measurements for Skin Deformations
Elastic Deformation- Day 1
|
2.44 mm
Standard Deviation 0.85
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|
BTC 2000 Measurements for Skin Deformations
Elastic Deformation- 3 Month post treatment
|
2.41 mm
Standard Deviation 0.87
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|
BTC 2000 Measurements for Skin Deformations
Ultimate Deformation-Day 1
|
2.59 mm
Standard Deviation 0.95
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|
BTC 2000 Measurements for Skin Deformations
Ultimate Deformation- 3 Month post treatment
|
2.57 mm
Standard Deviation 0.96
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SECONDARY outcome
Timeframe: Baseline (Day 1) and 3 month post treatmentPopulation: Analysis population includes all participants completing this assessment on day 1 and 3 month post treatment.
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar) This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. BTC 2000 was used for stiffness. Stiffness is measure in mmHg/mm and an increase in values of BTC measurements for stiffness would be seen as an improvement upon treatment.
Outcome measures
| Measure |
Skinpen Precision System
n=29 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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BTC 2000 Measurements for Stiffness
Stiffness- Day 1
|
165.24 mmHg/mm
Standard Deviation 65.92
|
|
BTC 2000 Measurements for Stiffness
Stiffness- 3 Month Post treatment
|
172.21 mmHg/mm
Standard Deviation 65.18
|
SECONDARY outcome
Timeframe: 1 month post treatmentPopulation: All
Subjects completed a Sponsor-provided questionnaire regarding improvement in wrinkles, satisfaction with the treatment, and willingness to recommend the treatment to friends and family members
Outcome measures
| Measure |
Skinpen Precision System
n=32 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
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|---|---|
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Patient Satisfaction Questionnaires
Do you notice any improvement in how your wrinkles look in the treated area? · Yes- 1 Month post treatment
|
30 Participants
|
|
Patient Satisfaction Questionnaires
Do you notice any improvement in how your wrinkles look in the treated area? · No-1 Month post Treatment
|
2 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in the number of wrinkles · Yes- 1 Month post treatment
|
12 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in the number of wrinkles · No-1 Month post Treatment
|
20 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in the size of wrinkles · Yes- 1 Month post treatment
|
25 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in the size of wrinkles · No-1 Month post Treatment
|
7 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in Pore Size · Yes- 1 Month post treatment
|
11 Participants
|
|
Patient Satisfaction Questionnaires
Reduction in Pore Size · No-1 Month post Treatment
|
21 Participants
|
|
Patient Satisfaction Questionnaires
Clearer skin · Yes- 1 Month post treatment
|
12 Participants
|
|
Patient Satisfaction Questionnaires
Clearer skin · No-1 Month post Treatment
|
20 Participants
|
|
Patient Satisfaction Questionnaires
Smoother skin texture · Yes- 1 Month post treatment
|
20 Participants
|
|
Patient Satisfaction Questionnaires
Smoother skin texture · No-1 Month post Treatment
|
12 Participants
|
|
Patient Satisfaction Questionnaires
More even skin tone (color) · Yes- 1 Month post treatment
|
13 Participants
|
|
Patient Satisfaction Questionnaires
More even skin tone (color) · No-1 Month post Treatment
|
19 Participants
|
|
Patient Satisfaction Questionnaires
Would you recommend this treatment to your friends and family · Yes- 1 Month post treatment
|
25 Participants
|
|
Patient Satisfaction Questionnaires
Would you recommend this treatment to your friends and family · No-1 Month post Treatment
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1, 3 Months post treatment.Population: The analysis population includes all participants completing this assessment.
Ultrasound measurements were performed using a 75 MHz ultrasonic transducer interfaced to a DUB 6100 OEM System (Taberna Pro Medicum, Lüneburg, Germany). Density and skin thickness measurements were obtained from the scans and increases in these values suggest a thickening of the epidermal and dermal tissue.
Outcome measures
| Measure |
Skinpen Precision System
n=26 Participants
The subject's Fine lines and wrinkles were treated with the skinpen precision system at depths of 2.5mm. The hydrogel was used in conjunction with the treatment to protect against abrasion and friction during the procedure.
|
|---|---|
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Ultrasound Measurements
Epidermal thickeness-Day 1
|
96.97 micro meter
Standard Deviation 52.99
|
|
Ultrasound Measurements
Epidermal thickness-3 Month Post Treatment
|
88.46 micro meter
Standard Deviation 26.21
|
|
Ultrasound Measurements
Epidermal Density-Day 1
|
62.74 micro meter
Standard Deviation 23.28
|
|
Ultrasound Measurements
Epidermal Density-3 M onth post treatment
|
53.46 micro meter
Standard Deviation 24.22
|
|
Ultrasound Measurements
Dermis Thickness-Day 1
|
1034.83 micro meter
Standard Deviation 247.72
|
|
Ultrasound Measurements
Dermis Thickness- 3 Month Post treatment
|
1092.08 micro meter
Standard Deviation 189.34
|
|
Ultrasound Measurements
Dermis Density- Day 1
|
28.87 micro meter
Standard Deviation 13.67
|
|
Ultrasound Measurements
Dermis Density- 3 Month Post treatment
|
27.99 micro meter
Standard Deviation 15.01
|
Adverse Events
Skinpen Precision System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Skinpen Precision System
n=35 participants at risk
Microneedle treatment to neck areas.
SkinPen Precision: Surgical instrument motors and accessories/attachments/Hydrogel
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Infections and infestations
Kidney infection
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Renal and urinary disorders
Kidney Stone removal
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Gastrointestinal disorders
Root canal
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Gastrointestinal disorders
Meniscus repair
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Nervous system disorders
Sleep Apnea
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Surgical and medical procedures
Biopsy on Jawline
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Infections and infestations
Viral Bronchitis
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
|
Surgical and medical procedures
Afib Cardioversion
|
2.9%
1/35 • Number of events 1 • The adverse event data were collected from Baseline up to 6 months post treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place