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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020690
• Other study ID #: YM-2023-003
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: September 9, 2025

Study information

• Verified date: October 2023
• Source: Enlight Medical Technologies (Shanghai) Co., Ltd
• Contact: Hu
• Phone: 08615221991087
• Email: echo_hu[@]enlight-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: September 9, 2025
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• bioabsorbable steroid-releasing stent
The patient after functional endoscopic sinus surgery to treat their chronic sinusitis, the experimental device or active comparator device will be implanted to the sinus to prevent re-intervention (surgery or medicine).

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Enlight Medical Technologies (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse event rate		immediately after the procedure
Primary	non reintervention rate	The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.	30 days
Secondary	Lund-Kennedy score	Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.	30 days, 90 days, 180 days and 1 year
Secondary	Lund-Mackay score	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.	90 days
Secondary	VAS score	A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.	30 days, 90 days, 180 days and 1 year
Secondary	sinus panty rate	as determined based on review of video endoscopic findings by an independent blinded surgeon	30 days, 90 days, 180 days and 1 year
Secondary	implantation successful rate		immediately after the procedure