RecruitingNCT07195877

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

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


Sponsor

Thread and Lift

Enrollment

127 participants

Start Date

Mar 31, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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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.


Locations(1)

Evamed/1Med

Hérouville-Saint-Clair, France

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NCT07195877