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China Post-Market Clinical Follow-up of FACILLE®

Sponsor
SciVision Biotech Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05294562
Collaborator
(none)
1,552
Enrollment
40.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1552 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    China Post-Market Clinical Follow-up of FACILLE®
    Actual Study Start Date :
    Dec 14, 2016
    Actual Primary Completion Date :
    May 7, 2017
    Actual Study Completion Date :
    May 12, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events reported during the study period [36 months]

      The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.

    Secondary Outcome Measures

    1. Subjects self-evaluating satisfaction [2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection]

      Patients rate their treatment satisfaction based on highly satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied.

    2. Subjects self-evaluating effectiveness [2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection]

      Patients rate their effectiveness based on effective and ineffective.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age 18 years or older of male or female;

    • Have used or plan to use FACILLE® Sodium Hyaluronate Gel for Injection;

    • Agree to participate and comply with the follow-up schedule of this study.

    Exclusion Criteria:

    • With a history of hypersensitivity or allergy to hyaluronic acid or any component of the device;

    • Other circumstances were judged to be unsuitable for participating in the study by the investigator.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • SciVision Biotech Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SciVision Biotech Inc.
    ClinicalTrials.gov Identifier:
    NCT05294562
    Other Study ID Numbers:
    • PMCF-FE01
    First Posted:
    Mar 24, 2022
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 24, 2022