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
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:
- Know history of allergy or intolerance to corticosteroids or mometasone furoate.
- 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).
- Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
- Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungalsinusitis.
- Glaucoma, ocular hypertension, posterior subcapsular cataracts.
- Known history of immune deficiency or concurrent condition requiring activechemotherapy and/or immunotherapy management for the disease.
- Clinical evidence of disease or condition expected to compromise survival or abilityto complete follow-up assessments during the 360 day follow-up period.
- Current ESS including frontal sinus surgery is aborted for any reason.
- Pregnant or lactating female
- Investigator determination that the potential study subject is unable to comply withstudy procedures and/or follow-up, or provided informed consent.
- 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,
ChinaActive - Recruiting
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