Recruiting NCT07195877
Real-life Assessement of Safety and Perofmance of the of the "Infinite-Thread®" Permanent Tensor Thread
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insertion/placement of tension threads.
- Who it may be relevant to
- Registry conditions: Face Tissue Elevation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
Overview
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.
Interventions
- Device 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 thre
Primary outcome measures
- To assess medical device safety at 5 years after intervention. [Time frame: at 5 years follow-up]
Secondary outcome measures (5)
- To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area) [Time frame: At 3-months, 1,2,3,4 and 5 years follow-up]
- To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area) [Time frame: At 3-months, 1,2,3,4 and 5 years follow-up]
- To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician. [Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up]
- To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area). [Time frame: At 3-months, 1,2,3,4 and 5 years follow-up]
- To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician). [Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Evamed/1Med — Hérouville-Saint-Clair
Identifiers
NCT: NCT07195877 · FILS-TENSEURS · 2024-A02819-38