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Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

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ClinicalTrials.gov Identifier: NCT02832674
Recruitment Status : Completed
First Posted : July 14, 2016
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
ThermiGen, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Skin Laxity
Intervention Device: Percutaneous Radiofrequency single treatment
Enrollment 72

Recruitment Details One hundred and twenty-one subjects were screened and 72 were enrolled. study initiation 25Jun2015.
Pre-assignment Details No significant events occurred during the study recruitment process.
Arm/Group Title Single Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 72
Completed 67
Not Completed 5
Arm/Group Title Single Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
52.9  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
64
  88.9%
Male
8
  11.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Hispanic or Latino
20
  27.8%
Not Hispanic or Latino
46
  63.9%
Unknown or Not Reported
6
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   2.8%
White
55
  76.4%
More than one race
1
   1.4%
Unknown or Not Reported
14
  19.4%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 72 participants
26.1  (2.9)
1.Primary Outcome
Title Tissue Lift at the Submental Area Measuring >/= 20 mm2
Hide Description A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
Time Frame Change from baseline at Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 72
Mean (90% Confidence Interval)
Unit of Measure: percentage of participants
56.9
(46.6 to 66.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Hide Description Overall improvement of submental lift was determined by a blinded rater panel using before and after photos
Time Frame Change from baseline to Days 90 and 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 66
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
Improvement Day 90 = Yes Number Analyzed 66 participants
74.2
(62 to 84.2)
Improvement Day 90 = No Number Analyzed 66 participants
25.8
(15.8 to 38)
Improvement Day 180 = Yes Number Analyzed 56 participants
71.4
(57.8 to 82.7)
Improvement Day 180 = No Number Analyzed 56 participants
28.6
(17.3 to 42.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments [Not Specified]
Type of Statistical Test Other
Comments Binomial test of proportions
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Physician Global Aesthetic Improvement Scale (P-GAIS)
Hide Description 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".
Time Frame Change from baseline at Days 90 and 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 69
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
Improvement Day 90 = Yes Number Analyzed 69 participants
94.2
(85.8 to 98.4)
Improvement Day 90 = No Number Analyzed 69 participants
5.8
(1.6 to 14.2)
Improvement Day 180 = Yes Number Analyzed 67 participants
89.6
(79.7 to 95.7)
Improvement Day 180 = No Number Analyzed 67 participants
10.4
(4.3 to 20.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Subject Global Aesthetic Improvement Scale (S-GAIS)
Hide Description 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.
Time Frame Change from baseline at Days 90 and 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 69
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
Improvement Day 90 = Yes Number Analyzed 69 participants
89.9
(80.2 to 95.8)
Improvement Day 90 = No Number Analyzed 69 participants
10.1
(4.2 to 19.8)
Improvement Day 180 = Yes Number Analyzed 67 participants
83.6
(72.5 to 91.5)
Improvement Day 180 = No Number Analyzed 67 participants
16.4
(8.5 to 27.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Physician Global Satisfaction Questionnaire (P-GSQ)
Hide Description 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.
Time Frame Change from baseline at Days 90 and 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 69
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
Improvement Day 90 = Yes Number Analyzed 69 participants
92.8
(83.9 to 97.6)
Improvement Day 90 = No Number Analyzed 69 participants
7.2
(2.4 to 16.1)
Improvement Day 180 = Yes Number Analyzed 67 participants
91
(81.5 to 96.6)
Improvement Day 180 = No Number Analyzed 67 participants
9
(3.4 to 18.5)
Satisfaction Day 90 = Yes Number Analyzed 69 participants
81.2
(69.9 to 89.6)
Satisfaction Day 90 = No Number Analyzed 69 participants
18.8
(10.4 to 30.1)
Satisfaction Day 180 = Yes Number Analyzed 67 participants
71.6
(59.3 to 82)
Satisfaction Day 180 = No Number Analyzed 67 participants
28.4
(18 to 40.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Subject Global Satisfaction Questionnaire (S-GSQ)
Hide Description 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.
Time Frame Change from baseline at Days 90 and 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Single Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 69
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
Improvement Day 90 = Yes Number Analyzed 69 participants
88.4
(78.4 to 94.9)
Improvement Day 90 = No Number Analyzed 69 participants
11.6
(5.1 to 21.6)
Improvement Day 180 = Yes Number Analyzed 67 participants
83.6
(72.5 to 91.5)
Improvement Day 180 = No Number Analyzed 67 participants
16.4
(8.5 to 27.5)
Satisfaction Day 90 = Yes Number Analyzed 69 participants
68.1
(55.8 to 78.8)
Satisfaction Day 90 = No Number Analyzed 69 participants
31.9
(21.2 to 44.1)
Satisfaction Day 180 = Yes Number Analyzed 67 participants
65.7
(53.1 to 76.8)
Satisfaction Day 180 = No Number Analyzed 67 participants
34.3
(23.2 to 46.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Treatment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse Events were collected from the time the subject signed the informed consent to last subject last visit. Duration was approximately 1.25 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Treatment
Hide Arm/Group Description

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.

All-Cause Mortality
Single Treatment
Affected / at Risk (%)
Total   0/72 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Single Treatment
Affected / at Risk (%) # Events
Total   1/72 (1.39%)    
Respiratory, thoracic and mediastinal disorders   
Retropharyngeal Swelling/Fluid  1 [1]  1/72 (1.39%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
[1]
Subject presented to the emergency room on Day 4th post treatment with pain. subject was admitted to the hospital for an unknown number of days. The event resolved two days later and the subject remained in the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Treatment
Affected / at Risk (%) # Events
Total   32/72 (44.44%)    
Gastrointestinal disorders   
Application Site Pain  1  7/72 (9.72%)  7
General disorders   
Application Site Hypoaesthesia  1  22/72 (30.56%)  23
Application Site Edema  1  16/72 (22.22%)  17
Application Site Swelling  1  8/72 (11.11%)  8
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Toni Fournier, Sr. VP New Products
Organization: ThermiGen LLC
Phone: 214-888-0634
Responsible Party: ThermiGen, LLC
ClinicalTrials.gov Identifier: NCT02832674     History of Changes
Other Study ID Numbers: THERMI_0005
First Submitted: June 10, 2016
First Posted: July 14, 2016
Results First Submitted: January 5, 2018
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018