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

Not Applicable

Recruiting

• Conditions: Chronic Sinusitis
• Interventions: Device: bioabsorbable steroid-releasing stent

• Registration Number: NCT06020690
• Lead Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-15
• Study Start: 2023-08-25
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-09-09
• Study Completion: 2025-09-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novabel bioabsorbable steroid-releasing stent	bioabsorbable steroid-releasing stent	-
marketed bioabsorbable steroid-releasing stent	bioabsorbable steroid-releasing stent	-

Primary Outcome Measures

Name	Time	Method
non reintervention rate	30 days	The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.

Secondary Outcome Measures

Name	Time	Method
sinus panty rate	30 days, 90 days, 180 days and 1 year	as determined based on review of video endoscopic findings by an independent blinded surgeon
Lund-Kennedy score	30 days, 90 days, 180 days and 1 year	Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
Lund-Mackay score	90 days	Each side of sinus is graded separately: 0 (no abnormality); 1 (partial opacification); 2 (complete opacification). If there is no frontal sinus (aplasia), the score is 0. Scores were calculated based on the results of a paranasal sinus CT scan 1-3 mm axial slice thickness with coronal and sagittal reconstruction. Result: score 0-24.
VAS score	30 days, 90 days, 180 days and 1 year	A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.
implantation successful rate	immediately after the procedure

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, China