Real-life Assessement of Safety and Perofmance of the of the "Infinite-Thread®" Permanent Tensor Thread

NCT07195877 — Recruiting, 127 participants, Thread and Lift

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory

RegistryNCT07195877
StatusRecruiting
Study typeObservational
Enrollment127 (Estimated)
SponsorThread and Lift (Industry); collaborators: EVAMED
ConditionsFace Tissue Elevation
InterventionsInsertion/placement of tension threads (Device)
Datesstart 2025-03-31, primary completion 2030-03-31 (estimated), completion 2030-03-31 (estimated), first posted 2025-09-29, last updated 2025-09-29
Locations1 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.

Expand all sections  ·  Collapse all

+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)

FacilityCityCountryStatus
Evamed/1MedHérouville-Saint-ClairFranceRecruiting