A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis

Last updated: October 24, 2023
Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sinus Infections

Sinusitis

Rhinitis, Allergic, Perennial

Treatment

bioabsorbable steroid-releasing stent

Clinical Study ID

NCT06020690
YM-2023-003
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to learn about the safety and effectiveness of Novabel bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to answer are:

  • The safety of this device for the chronic sinusitis

  • The effectiveness of this device for the chronic sinusitis Participants will be implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure.

Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronicrhinosinusitis (2018), who were scheduled to undergo primary or revision bilateralESS.
  • Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay [L-M] score of <=3 on each side).
  • Can understand the purpose of this study and will to join and finish all the follow upaccording to the study. Sign the ICF.

Exclusion

Exclusion Criteria:

  1. Know history of allergy or intolerance to corticosteroids or mometasone furoate.
  2. The subject has a known allergic reaction or contraindication to the device materialand its degradation products (L-polylactic acid, racemic polylactic acid, lactidelactate, lactic acid).
  3. Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
  4. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungalsinusitis.
  5. Glaucoma, ocular hypertension, posterior subcapsular cataracts.
  6. Known history of immune deficiency or concurrent condition requiring activechemotherapy and/or immunotherapy management for the disease.
  7. Clinical evidence of disease or condition expected to compromise survival or abilityto complete follow-up assessments during the 360 day follow-up period.
  8. Current ESS including frontal sinus surgery is aborted for any reason.
  9. Pregnant or lactating female
  10. Investigator determination that the potential study subject is unable to comply withstudy procedures and/or follow-up, or provided informed consent.
  11. Currently involved in another clinical study where that participation may conflict orinterfere with the treatment, follow-up or results of the clinical study.

Study Design

Total Participants: 93
Treatment Group(s): 1
Primary Treatment: bioabsorbable steroid-releasing stent
Phase:
Study Start date:
August 25, 2023
Estimated Completion Date:
September 09, 2025

Connect with a study center

  • Qilu Hospital of Shandong University

    Jinan,
    China

    Active - Recruiting

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