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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

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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