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

Recruiting

• Conditions: Face Tissue Elevation

• Registration Number: NCT07195877
• Lead Sponsor: Thread and Lift

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-31
• Study First Submitted: 2025-08-20
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess medical device safety at 5 years after intervention.	at 5 years follow-up	The rate of sequelae and complications related to the device or procedure within 5 years after the intervention

Secondary Outcome Measures

Name	Time	Method
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area)	At 3-months, 1,2,3,4 and 5 years follow-up	Completion of effectiveness score by patient (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area)	At 3-months, 1,2,3,4 and 5 years follow-up	Completion of effectiveness score by physician (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician.	At 3 months, 1, 2, 3, 4, and 5 years follow-up	Physician effectiveness scale (5-point ordinal scales) by area. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area).	At 3-months, 1,2,3,4 and 5 years follow-up	Completion of effectiveness score by independant assessor (physician) (GAIS) (overall and by area). Blind analysis of picture.; It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician).	At 3 months, 1, 2, 3, 4, and 5 years follow-up	Independent assessor (physican) effectiveness scale (5-point ordinal scales) by area. Blind analysis of picture.; Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).

Trial Locations

Locations (1)

Evamed/1Med; 🇫🇷 Hérouville-Saint-Clair, France