The purpose of this post-market clinical follow-up is to assess the safety and performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face. The study will assess the safety result up to 5 years after the intervention.
Study Type
OBSERVATIONAL
Enrollment
127
* Standard preoperative anti-staphylococcal antibiotic prophylaxis by intramuscular injection. * Disinfection of the surgical area. * Marking of the paths of the threads to be implanted according to the physician's choice. * Placement of sterile surgical drapes. * Local anesthesia of the paths. * Implantation of a needle (manufactured by Thread \& Lift) and pulling of the threads into the subcutaneous tissue. Adjustment of the tension of all the implanted threads. Cutting of the ends of the threads.
Evamed/1Med
Hérouville-Saint-Clair, France
RECRUITINGTo assess medical device safety at 5 years after intervention.
The rate of sequelae and complications related to the device or procedure within 5 years after the intervention
Time frame: at 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area)
Completion of effectiveness score by patient (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area)
Completion of effectiveness score by physician (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician.
Physician effectiveness scale (5-point ordinal scales) by area. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).
Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area).
Completion of effectiveness score by independant assessor (physician) (GAIS) (overall and by area). Blind analysis of picture. It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician).
Independent assessor (physican) effectiveness scale (5-point ordinal scales) by area. Blind analysis of picture. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).
Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up