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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: bioabsorbable steroid-releasing stent

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu; Phone Number: 08615221991087; Email: echo_hu@enlight-medical.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Qilu Hospital of Shandong University
    • Contact: Li
    • Principal Investigator: Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novabel bioabsorbable steroid-releasing stent	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).; Other Names: functional endoscopic sinus surgery
Active Comparator: marketed bioabsorbable steroid-releasing stent	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).; Other Names: functional endoscopic sinus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
implantation successful rate		immediately after the procedure

Other Outcome Measures

Outcome Measure	Time Frame
adverse event rate	immediately after the procedure

Collaborators and Investigators

• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd
• Investigators: Principal Investigator: Li, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): September 9, 2024
• Study Completion (Estimated): September 9, 2025

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: bioabsorbable; steroid-releasing stent
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: YM-2023-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No