NCT Number: NCT07195877
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hérouville-Saint-Clair, 14200, France
Location status: Recruiting
Caroline BARTOLIN
PRINCIPAL_INVESTIGATOR
Jean-Paul FOUMENTEZE
PRINCIPAL_INVESTIGATOR
Justine COLOMBEL
CONTACT
Marion DELBAERE
PRINCIPAL_INVESTIGATOR
Thierry BESINS
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 5 years follow-up
The rate of sequelae and complications related to the device or procedure within 5 years after the intervention
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Thread and Lift
Industry
Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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