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

NCT06020690 | Unknown

• 1 other identifier: YM-2023-003
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis

Keywords

bioabsorbable; steroid-releasing stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Lund-Kennedy score

  30 days, 90 days, 180 days and 1 year

• Lund-Mackay score

  90 days

• VAS score

  30 days, 90 days, 180 days and 1 year

• sinus panty rate

  30 days, 90 days, 180 days and 1 year

• implantation successful rate

  immediately after the procedure

Other Outcomes (1)

• adverse event rate

  immediately after the procedure

Study Arms (2)

Novabel bioabsorbable steroid-releasing stent

EXPERIMENTAL

Device: bioabsorbable steroid-releasing stent

marketed bioabsorbable steroid-releasing stent

ACTIVE COMPARATOR

Device: bioabsorbable steroid-releasing stent

Interventions

bioabsorbable steroid-releasing stent DEVICE

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).

Also known as: functional endoscopic sinus surgery

Novabel bioabsorbable steroid-releasing stent; marketed bioabsorbable steroid-releasing stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Know history of allergy or intolerance to corticosteroids or mometasone furoate.
• 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).
• Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
• Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
• Glaucoma, ocular hypertension, posterior subcapsular cataracts.
• Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
• Clinical evidence of disease or condition expected to compromise survival or ability to 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 with study procedures and/or follow-up, or provided informed consent.
• Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.

Sponsors & Collaborators

• Enlight Medical Technologies (Shanghai) Co., Ltd: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

Study Officials

• Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu

CONTACT

08615221991087; echo_hu@enlight-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 1, 2023
• Study Start: August 25, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)