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Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.
RECRUITINGSponsored by 1st SurgiConcept
Actively Recruiting
Sponsor1st SurgiConcept
Started2023-02-16
Est. completion2025-03
Eligibility
Age35 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05746078
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
Age: 35 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: * Men / women aged 35 to 75 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.
Conditions3
CancerPtosisPtosis, Mild
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Actively Recruiting
Sponsor1st SurgiConcept
Started2023-02-16
Est. completion2025-03
Eligibility
Age35 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05746078