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

Sponsor
1st SurgiConcept (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05746078
Collaborator
EVAMED (Other)
99
2
64.5
49.5
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    99 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
    Actual Study Start Date :
    Feb 16, 2023
    Actual Primary Completion Date :
    Feb 16, 2023
    Anticipated Study Completion Date :
    Jul 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Investigator Global Aesthetic Improvement Scale (IGAIS) [At 12 months]

      Proportion of patients with an IGAIS score between 1 and 3 showing an improvement of ptosis. This item is scaled from 1 to 5, 5 being the worst value.

    Secondary Outcome Measures

    1. Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale) [Day 0 to Year 5.]

      The patient satisfaction with SGAIS score will be assessed at each visit. This item is scaled from 1 to 5, 5 being the worst value.

    2. Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale) [Day 0 to month 24]

      The surgeon satisfaction with the IGAIS score will be assessed from intervention (day 0) to 12 months. This item is scaled from 1 to 5, 5 being the worst value.

    3. Improvement of overall facial appearance [Day 0 to Year 5.]

      The improvement of overall facial appearance (harmony) will be assessed using a 5-point patient satisfaction scale. The worst value is very unsatisfied and the highest value is very satisfied.

    4. Age of face [Day 0 to year 5.]

      The age of patient face will be assessed a specific question at each visit.

    5. Safety of SPRING THREAD® Elastic Tensor Thread [Day 0 to month 12.]

      All adverse event will be assessed for the study duration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Men / women aged 40 to 70 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Henri Mondor Créteil France
    2 Hôpital Henri Mondor Créteil France

    Sponsors and Collaborators

    • 1st SurgiConcept
    • EVAMED

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    1st SurgiConcept
    ClinicalTrials.gov Identifier:
    NCT05746078
    Other Study ID Numbers:
    • ESTES
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 1st SurgiConcept
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 27, 2023