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

Recruiting
35 - 75 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Ptosis, Ptosis, Mild

NCT05746078

1st SurgiConcept

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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