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

T

Thread and Lift

Status

Enrolling

Conditions

Face Tissue Elevation

Treatments

Device: Insertion/placement of tension threads

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT07195877
FILS-TENSEURS
2024-A02819-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

127 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Vincent FOUMENTEZE

Data sourced from clinicaltrials.gov

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