Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
| Registry | NCT07195877 |
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 127 (Estimated) |
| Sponsor | Thread and Lift (Industry); collaborators: EVAMED |
| Conditions | Face Tissue Elevation |
| Interventions | Insertion/placement of tension threads (Device) |
| Dates | start 2025-03-31, primary completion 2030-03-31 (estimated), completion 2030-03-31 (estimated), first posted 2025-09-29, last updated 2025-09-29 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Face Tissue Elevation All trials of Insertion/placement of tension threads
-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.
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+Arms and interventions
- Insertion/placement of tension threads (Device): * 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.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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).
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Evamed/1Med | Hérouville-Saint-Clair | France | Recruiting |