Chronic SinusitisNCT06020690
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
A study testing bioabsorbable steroid-releasing stent in people with Chronic Sinusitis, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- bioabsorbable steroid-releasing stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan
Li
Li
About this study
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
- Being tested
- bioabsorbable steroid-releasing stent
- Keywords
- bioabsorbable, steroid-releasing stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioabsorbable steroid-releasing stentDevice
Also called functional endoscopic sinus surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Novabel bioabsorbable steroid-releasing stent | Experimental | Not described Receives: Device: bioabsorbable steroid-releasing stent |
| marketed bioabsorbable steroid-releasing stent | Active comparator | Not described Receives: Device: bioabsorbable steroid-releasing stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (5)
Lund-Kennedy score
Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 30 days, 90 days, 180 days and 1 year
implantation successful rate
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start25 Aug 2023
- Primary completion9 Sep 2024 (estimated)
- Study completion9 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020690
- Sponsor's protocol ID
- YM-2023-003
- Status last verified
- Oct 2023
- First submitted
- 15 Aug 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT06020690
- Acronym / sponsor ID
- YM-2023-003
- Conditions
- Chronic Sinusitis
- Keywords
- bioabsorbable, steroid-releasing stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 9 Sep 2024 (estimated)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novabel bioabsorbable steroid-releasing stent | Experimental | Device: bioabsorbable steroid-releasing stent |
| marketed bioabsorbable steroid-releasing stent | Active comparator | Device: bioabsorbable steroid-releasing stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioabsorbable steroid-releasing stentAlso: functional endoscopic sinus surgeryThe 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). | Device | Novabel bioabsorbable steroid-releasing stent, marketed bioabsorbable steroid-releasing stent |
Primary outcome
non reintervention rate
Time frame: 30 days
The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.
5 secondary outcomes
Lund-Kennedy score
Time frame: 30 days, 90 days, 180 days and 1 year
Lund-Mackay score
Time frame: 90 days
VAS score
Time frame: 30 days, 90 days, 180 days and 1 year
sinus panty rate
Time frame: 30 days, 90 days, 180 days and 1 year
implantation successful rate
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioabsorbable steroid-releasing stent in people with Chronic Sinusitis, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu (08615221991087, echo_hu@enlight-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non reintervention rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.