An interventional study of bioabsorbable steroid-releasing stent in Chronic Sinusitis, sponsored by Enlight Medical Technologies (Shanghai) Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Enlight Medical Technologies (Shanghai) Co., Ltd · Not applicable, Interventional, and Treatment
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:
Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.
256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.
This study's planned enrollment of 93 is above the median of 60 across 196 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Enlight Medical Technologies (Shanghai) Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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).
Also known as: functional endoscopic sinus surgery
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.
Time frame: 30 days
Lund-Kennedy score
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
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.
Time frame: 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.
Time frame: 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
Time frame: 30 days, 90 days, 180 days and 1 year
implantation successful rate
Time frame: immediately after the procedure
adverse event rate
Time frame: immediately after the procedure
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Enlight Medical Technologies (Shanghai) Co., Ltd