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

Study acronym: ESTES
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date changed from estimate of Mar 2025 to Feb 7, 2026 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Mar 2029 to Dec 2030
    • Study sites: 3 to 2
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Notable Primary completion date: Feb 16, 2023 to Mar 2025
    • Study sites: 4 to 3
    • Study completion date: Jul 1, 2028 to Mar 2029
    v3
  3. Minor Study sites: 2 to 4
    • Eligibility criteria revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05746078
Lead Sponsor 1st SurgiConcept
Collaborators: EVAMED
Conditions
(from sponsor)
Ptosis, Ptosis, Mild
Related terms Blepharoptosis, Lymphoma, Follicular
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov