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

Last updated: December 9, 2024
Sponsor: 1st SurgiConcept
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT05746078
ESTES
  • Ages 35-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without ahistory 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

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 priorto the study.

  • Patients treated with long-term systemic corticosteroids.

  • Patients with visceral failure, chronic immunological pathology, pregnant orbreasfeading 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 Design

Total Participants: 99
Study Start date:
February 16, 2023
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Hôpital Henri Mondor

    Créteil,
    France

    Active - Recruiting

  • Centre Massilien de la Face

    Marseille, 13006
    France

    Site Not Available

  • Hôpital Pierre Paul Riquet

    Toulouse, 31000
    France

    Site Not Available

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