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Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One hundred and twenty-one subjects were screened and 72 were enrolled. study initiation 25Jun2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events occurred during the study recruitment process.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Single Treatment
STARTED   72 
COMPLETED   67 
NOT COMPLETED   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Single Treatment 
Overall Participants Analyzed 
[Units: Participants]
 72 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.9  (7.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      64  88.9% 
Male      8  11.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      20  27.8% 
Not Hispanic or Latino      46  63.9% 
Unknown or Not Reported      6   8.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.1  (2.9) 


  Outcome Measures

1.  Primary:   Tissue Lift at the Submental Area Measuring >/= 20 mm2   [ Time Frame: Change from baseline at Day 90 ]

2.  Secondary:   Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer   [ Time Frame: Change from baseline to Days 90 and 180 ]

3.  Secondary:   Physician Global Aesthetic Improvement Scale (P-GAIS)   [ Time Frame: Change from baseline at Days 90 and 180 ]

4.  Secondary:   Subject Global Aesthetic Improvement Scale (S-GAIS)   [ Time Frame: Change from baseline at Days 90 and 180 ]

5.  Secondary:   Physician Global Satisfaction Questionnaire (P-GSQ)   [ Time Frame: Change from baseline at Days 90 and 180 ]

6.  Secondary:   Subject Global Satisfaction Questionnaire (S-GSQ)   [ Time Frame: Change from baseline at Days 90 and 180 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: TFournier@Thermi.com



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