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

Primary Purpose

Chronic Sinusitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bioabsorbable steroid-releasing stent
Sponsored by
Enlight Medical Technologies (Shanghai) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring bioabsorbable, steroid-releasing stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Qilu Hospital of Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novabel bioabsorbable steroid-releasing stent

marketed bioabsorbable steroid-releasing stent

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lund-Kennedy score
Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
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.
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.
sinus panty rate
as determined based on review of video endoscopic findings by an independent blinded surgeon
implantation successful rate

Full Information

First Posted
August 15, 2023
Last Updated
August 28, 2023
Sponsor
Enlight Medical Technologies (Shanghai) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06020690
Brief Title
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Official Title
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
September 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enlight Medical Technologies (Shanghai) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
bioabsorbable, steroid-releasing stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novabel bioabsorbable steroid-releasing stent
Arm Type
Experimental
Arm Title
marketed bioabsorbable steroid-releasing stent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
bioabsorbable steroid-releasing stent
Other Intervention Name(s)
functional endoscopic sinus surgery
Intervention Description
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).
Primary Outcome Measure Information:
Title
non reintervention rate
Description
The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Lund-Kennedy score
Description
Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
Time Frame
30 days, 90 days, 180 days and 1 year
Title
Lund-Mackay score
Description
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.
Time Frame
90 days
Title
VAS score
Description
A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.
Time Frame
30 days, 90 days, 180 days and 1 year
Title
sinus panty rate
Description
as determined based on review of video endoscopic findings by an independent blinded surgeon
Time Frame
30 days, 90 days, 180 days and 1 year
Title
implantation successful rate
Time Frame
immediately after the procedure
Other Pre-specified Outcome Measures:
Title
adverse event rate
Time Frame
immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu
Phone
08615221991087
Email
echo_hu@enlight-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li
First Name & Middle Initial & Last Name & Degree
Li

12. IPD Sharing Statement

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

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