Colombelles

Researchers are monitoring the safety and performance of the Infinite-Threadae Permanent Tensor Thread used on the face. This post-market follow-up study will evaluate how well the device works and its safety up to five years after it is placed. The research is sponsored by Thread and Lift and focuses on people receiving this facial tissue elevation treatment. Participants will receive the Infinite-Threadae permanent tension thread through a procedure that involves disinfection, local anesthesia, and inserting threads under the skin using a special needle. Before the procedure, a standard antibiotic injection is given to prevent infection. The thread tension is adjusted and excess thread ends are cut. The study observes participants over multiple timepoints up to five years after the initial intervention to assess the devices effect. Participants will be followed for five years, with evaluations at 3 months, 1, 2, 3, 4, and 5 years after the thread placement. During these visits, both the participant and physicians will assess the effectiveness of the thread overall and by facial area. Independent assessors will also evaluate the results. The main safety outcome is assessed at five years. Participants must meet eligibility requirements and agree to avoid other major facial procedures during the follow-up period.