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NCT05746078
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.
Conditions: Ptosis, Ptosis, Mild
Sex: All
Ages: 40 Years – 70 Years
Enrollment: 99
Sponsor: 1st SurgiConcept
Location: France
Summary
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread.
The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.
Eligibility Criteria
Inclusion Criteria:Men / women aged 40 to 70 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift).Patient able to understand the explanations given.Patient informed and not objecting to participate in the study.Patient able to comply with protocol requirements, including follow-up visits.Patient affiliated to social security.Exclusion Criteria:Patient unable to understand study information and attend study visits.Patient did not give consent to participate.Patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study.Patients treated with long-term systemic corticosteroids.Patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women.Patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion.Patient refusing to participate in the clinical investigation.
Source: ClinicalTrials.gov (NCT05746078). StuddyBuddy aggregates publicly available trial information.