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

1st SurgiConcept

Status: Enrolling

Conditions: Ptosis, Mild; Ptosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05746078

ESTES

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.