Trial Outcomes & Findings for Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift (NCT NCT02832674)
NCT ID: NCT02832674
Last Updated: 2018-05-01
Results Overview
A \>/= 20 mm\^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Change from baseline at Day 90
Results posted on
2018-05-01
Participant Flow
One hundred and twenty-one subjects were screened and 72 were enrolled. study initiation 25Jun2015.
No significant events occurred during the study recruitment process.
Participant milestones
| Measure |
Single Treatment
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Overall Study
STARTED
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72
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Overall Study
COMPLETED
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67
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
Baseline characteristics by cohort
| Measure |
Single Treatment
n=72 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Age, Continuous
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52.9 years
STANDARD_DEVIATION 7.0 • n=5 Participants
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Sex: Female, Male
Female
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64 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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20 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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46 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
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Race (NIH/OMB)
White
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55 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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14 Participants
n=5 Participants
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Body Mass Index
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26.1 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
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PRIMARY outcome
Timeframe: Change from baseline at Day 90A \>/= 20 mm\^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
Outcome measures
| Measure |
Single Treatment
n=72 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Tissue Lift at the Submental Area Measuring >/= 20 mm2
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56.9 percentage of participants
Interval 46.6 to 66.9
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SECONDARY outcome
Timeframe: Change from baseline to Days 90 and 180Population: sixty-nine of the 72 enrolled and treated subjects completed visit 5 (Day 90) and 67 completed Visit 6 (Day 180). subjects with non-evaluable images were excluded from the analysis for Day 90 and 180 as applicable
Overall improvement of submental lift was determined by a blinded rater panel using before and after photos
Outcome measures
| Measure |
Single Treatment
n=66 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Improvement Day 90 = Yes
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74.2 percentage of participants
Interval 62.0 to 84.2
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Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Improvement Day 90 = No
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25.8 percentage of participants
Interval 15.8 to 38.0
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Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Improvement Day 180 = Yes
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71.4 percentage of participants
Interval 57.8 to 82.7
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Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Improvement Day 180 = No
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28.6 percentage of participants
Interval 17.3 to 42.2
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SECONDARY outcome
Timeframe: Change from baseline at Days 90 and 180Population: of the 72 enrolled and treated subjects, 69 completed Day 90 and 67 completed the Day 180 visit (4 subjects were lost to follow up and 1 withdrew consent)
A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from "Very much improved" to "worse".
Outcome measures
| Measure |
Single Treatment
n=69 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Physician Global Aesthetic Improvement Scale (P-GAIS)
Improvement Day 90 = Yes
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94.2 percentage of participants
Interval 85.8 to 98.4
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Physician Global Aesthetic Improvement Scale (P-GAIS)
Improvement Day 90 = No
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5.8 percentage of participants
Interval 1.6 to 14.2
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Physician Global Aesthetic Improvement Scale (P-GAIS)
Improvement Day 180 = Yes
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89.6 percentage of participants
Interval 79.7 to 95.7
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Physician Global Aesthetic Improvement Scale (P-GAIS)
Improvement Day 180 = No
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10.4 percentage of participants
Interval 4.3 to 20.3
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SECONDARY outcome
Timeframe: Change from baseline at Days 90 and 180Population: of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 completed day 180 (4 subjects were lost to follow up and 1 subject withdrew consent)
A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to "lift"is measured from. the 5-point scale measures from Very much improved to worse.
Outcome measures
| Measure |
Single Treatment
n=69 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Subject Global Aesthetic Improvement Scale (S-GAIS)
Improvement Day 90 = Yes
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89.9 percentage of participants
Interval 80.2 to 95.8
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Subject Global Aesthetic Improvement Scale (S-GAIS)
Improvement Day 90 = No
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10.1 percentage of participants
Interval 4.2 to 19.8
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Subject Global Aesthetic Improvement Scale (S-GAIS)
Improvement Day 180 = Yes
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83.6 percentage of participants
Interval 72.5 to 91.5
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Subject Global Aesthetic Improvement Scale (S-GAIS)
Improvement Day 180 = No
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16.4 percentage of participants
Interval 8.5 to 27.5
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SECONDARY outcome
Timeframe: Change from baseline at Days 90 and 180Population: Of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 the Day 180 (4 subjects were lost to follow up and one withdrew consent).
A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.
Outcome measures
| Measure |
Single Treatment
n=69 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Physician Global Satisfaction Questionnaire (P-GSQ)
Improvement Day 90 = Yes
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92.8 percentage of participants
Interval 83.9 to 97.6
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Physician Global Satisfaction Questionnaire (P-GSQ)
Improvement Day 90 = No
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7.2 percentage of participants
Interval 2.4 to 16.1
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Physician Global Satisfaction Questionnaire (P-GSQ)
Improvement Day 180 = Yes
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91 percentage of participants
Interval 81.5 to 96.6
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Physician Global Satisfaction Questionnaire (P-GSQ)
Improvement Day 180 = No
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9 percentage of participants
Interval 3.4 to 18.5
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Physician Global Satisfaction Questionnaire (P-GSQ)
Satisfaction Day 90 = Yes
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81.2 percentage of participants
Interval 69.9 to 89.6
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Physician Global Satisfaction Questionnaire (P-GSQ)
Satisfaction Day 90 = No
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18.8 percentage of participants
Interval 10.4 to 30.1
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Physician Global Satisfaction Questionnaire (P-GSQ)
Satisfaction Day 180 = Yes
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71.6 percentage of participants
Interval 59.3 to 82.0
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Physician Global Satisfaction Questionnaire (P-GSQ)
Satisfaction Day 180 = No
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28.4 percentage of participants
Interval 18.0 to 40.7
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SECONDARY outcome
Timeframe: Change from baseline at Days 90 and 180Population: Of the 72 enrolled and treated subjects, 69 completed the day 90 visit and 67 completed the day 180 visit (4 subjects were lost to follow up and one subject withdrew consent)
A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.
Outcome measures
| Measure |
Single Treatment
n=69 Participants
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Subject Global Satisfaction Questionnaire (S-GSQ)
Improvement Day 90 = Yes
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88.4 percentage of participants
Interval 78.4 to 94.9
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Subject Global Satisfaction Questionnaire (S-GSQ)
Improvement Day 90 = No
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11.6 percentage of participants
Interval 5.1 to 21.6
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Subject Global Satisfaction Questionnaire (S-GSQ)
Improvement Day 180 = Yes
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83.6 percentage of participants
Interval 72.5 to 91.5
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Subject Global Satisfaction Questionnaire (S-GSQ)
Improvement Day 180 = No
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16.4 percentage of participants
Interval 8.5 to 27.5
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Subject Global Satisfaction Questionnaire (S-GSQ)
Satisfaction Day 90 = Yes
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68.1 percentage of participants
Interval 55.8 to 78.8
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Subject Global Satisfaction Questionnaire (S-GSQ)
Satisfaction Day 90 = No
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31.9 percentage of participants
Interval 21.2 to 44.1
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Subject Global Satisfaction Questionnaire (S-GSQ)
Satisfaction Day 180 = Yes
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65.7 percentage of participants
Interval 53.1 to 76.8
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Subject Global Satisfaction Questionnaire (S-GSQ)
Satisfaction Day 180 = No
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34.3 percentage of participants
Interval 23.2 to 46.9
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Adverse Events
Single Treatment
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Treatment
n=72 participants at risk
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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Respiratory, thoracic and mediastinal disorders
Retropharyngeal Swelling/Fluid
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1.4%
1/72 • Number of events 1 • Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
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Other adverse events
| Measure |
Single Treatment
n=72 participants at risk
All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'
Percutaneous Radiofrequency single treatment: Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
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General disorders
Application Site Hypoaesthesia
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30.6%
22/72 • Number of events 23 • Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
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General disorders
Application Site Edema
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22.2%
16/72 • Number of events 17 • Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
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Gastrointestinal disorders
Application Site Pain
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9.7%
7/72 • Number of events 7 • Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
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General disorders
Application Site Swelling
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11.1%
8/72 • Number of events 8 • Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60