Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.

Conditions
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Ptosis, Ptosis, Mild

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Aesthetic Improvement Scale (IGAIS) | Proportion of patients with an IGAIS score between 1 and 3 showing an improvement of ptosis. This item is scaled from 1 to 5, 5 being the worst value. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale) | The patient satisfaction with SGAIS score will be assessed at each visit. This item is scaled from 1 to 5, 5 being the worst value. | Day 0 to Year 5. | 
| Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale) | The surgeon satisfaction with the IGAIS score will be assessed from intervention (day 0) to 12 months. This item is scaled from 1 to 5, 5 being the worst value. | Day 0 to month 24 | 
| Improvement of overall facial appearance | The improvement of overall facial appearance (harmony) will be assessed using a 5-point patient satisfaction scale. The worst value is very unsatisfied and the highest value is very satisfied. | Day 0 to Year 5. | 
| Age of face | The age of patient face will be assessed a specific question at each visit. | Day 0 to year 5. | 
| Safety of SPRING THREAD® Elastic Tensor Thread | All adverse event will be assessed for the study duration. | Day 0 to month 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ptosis, Moderate