Face Tissue Elevation
Conditions
Keywords
Tissue elevation, Infinite-Thread, Face, Aesthetic, Infinite-Thread®, permanent tensor thread, Thread&Lift
Brief summary
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.
Interventions
DEVICEInsertion/placement of tension threads
* 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.
Sponsors
EVAMED
Thread and Lift
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject aged 18 years or older * Subject informed and not opposed to participating in the study * Subject to be implanted with at least one Infinite-Thread® tension thread * Person affiliated with a heallth care system/inssurance
Exclusion criteria
* Pregnant or breastfeeding women * Contraindications (allergy to components, infection, systemic diseases) * Subject prones to chronic pain * Person deprived of liberty, under guardianship/curatorship, or under judicial protection * Subject refusing to commit to not resorting to the following procedures during the 5 years following their intervention: Surgical facelift, Deep phenol peel, CO2 laser resurfacing & Lipofilling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess medical device safety at 5 years after intervention. | at 5 years follow-up | The rate of sequelae and complications related to the device or procedure within 5 years after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area) | At 3-months, 1,2,3,4 and 5 years follow-up | 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. |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area) | At 3-months, 1,2,3,4 and 5 years follow-up | 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. |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician. | At 3 months, 1, 2, 3, 4, and 5 years follow-up | 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). |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area). | At 3-months, 1,2,3,4 and 5 years follow-up | 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. |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician). | At 3 months, 1, 2, 3, 4, and 5 years follow-up | 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). |
Countries
France
Contacts
Primary ContactVincent FOUMENTEZE
Outcome results
None listed