Evaluating a new bioabsorbable steroid-releasing stent for chronic sinusitis

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

This study is testing a new type of stent that releases steroids to see if it helps people with chronic sinusitis feel better after surgery compared to a standard stent.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Jinan)
• Trial ID: NCT06020690 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Novabel bioabsorbable steroid-releasing stent in patients with chronic sinusitis. Participants will receive the stent following functional endoscopic sinus surgery (FESS) and will return for follow-up evaluations at various intervals up to one year. The study will compare the Novabel stent to a marketed device to determine if their safety and effectiveness are non-inferior. The trial is designed to provide insights into the potential benefits of this innovative treatment for chronic sinusitis.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with chronic rhinosinusitis scheduled for primary or revision bilateral endoscopic sinus surgery.

Not a fit: Patients with a history of allergy to corticosteroids or those with conditions like cystic fibrosis or sinonasal tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for managing chronic sinusitis.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using bioabsorbable devices for sinus conditions, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ESS.
* 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 up according to the study. Sign the ICF.

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 material and its degradation products (L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid).
3. Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
4. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
5. Glaucoma, ocular hypertension, posterior subcapsular cataracts.
6. Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
7. Clinical evidence of disease or condition expected to compromise survival or ability to 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 with study procedures and/or follow-up, or provided informed consent.
11. Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.

Where this trial is running

Jinan

• Qilu Hospital of Shandong University — Jinan, China (Recruiting)

Study contacts

• Principal investigator: Li — Qilu Hospital of Shandong University
• Study coordinator: Hu

Conditions Chronic Sinusitis; bioabsorbable; steroid-releasing stent