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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2030-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Face Tissue Elevation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Insertion/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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No