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

Recruiting now

Conditions studied: Ptosis, Ptosis, Mild

In brief

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.

Key facts

Study ID

NCT05746078

Run by

1st SurgiConcept

People needed

99

Starts

2023-02-16

Expected to finish

2029-03-01

Last updated by the study team

2024-12-12

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hôpital Henri Mondor — Créteil, France (enrolling)
• Hôpital Henri Mondor — Créteil, France (enrolling)
• Hôpital Pierre Paul Riquet — Toulouse, France

Full record on ClinicalTrials.gov

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