Safety and performance of the Infinite-Thread permanent facial tension thread
Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
This project will test if the Infinite-Thread permanent tension thread is safe and effective for adults receiving facial tissue elevation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 127 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thread and Lift Industry-sponsored |
| Locations | 1 site (Hérouville-Saint-Clair) |
| Trial ID | NCT07195877 on ClinicalTrials.gov |
What this trial studies
This post-market clinical follow-up will observe adults implanted with at least one Infinite-Thread permanent tensor thread and follow them for up to five years to record safety and performance outcomes. Data collection will include adverse events, device integrity, and clinical measures of tissue elevation reported by treating clinicians and patients. The study excludes pregnant or breastfeeding women and people with specific contraindications or who plan certain facial procedures during follow-up. The sponsor is Thread and Lift, with the investigation conducted at Evamed/1Med in Hérouville-Saint-Clair in collaboration with EVAMED.
Who should consider this trial
Good fit: Adults aged 18 or older who are receiving at least one Infinite-Thread implant for facial tissue elevation and can commit to five years of follow-up are the intended participants.
Not a fit: People who are pregnant or breastfeeding, allergic to device components, have active infections or certain systemic diseases, chronic pain conditions, or who plan a surgical facelift, deep phenol peel, CO2 resurfacing, or lipofilling within five years are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a longer-term, minimally invasive option for facial tissue elevation with safety data through five years.
How similar studies have performed: Thread-based facial lifting procedures have been reported with varied results in the literature, but long-term post‑market data specific to the Infinite-Thread device are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hérouville-Saint-Clair
- Evamed/1Med — Hérouville-Saint-Clair, France (Recruiting)
Study contacts
- Study coordinator: Vincent FOUMENTEZE
- Email: foumentezevincent@threadandlift.com
- Phone: +32 (0) 468 38 72 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.