rhinitis
Conditions
Interventions
Experiment:BISORB
Control:Naximian
Sponsors
The Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects aged 18-65 years old, male or non-pregnant women; 2. subjects / statutory authorized representatives understand the purpose and procedures of the trial and voluntarily sign the informed consent form; 3. Subjects must meet the diagnostic criteria of chronic sinusitis, diagnosed with bilateral chronic sinusitis, to be confirmed by CT examination of both Lund-Mackay score of 26 points (3 months before the CT examination is valid); 4. Female subjects did not breast-feed during screening visits, no breastfeeding for up to 1 year after the start of surgery, pregnancy planning; 5. subjects did not participate in the first three months of other clinical trials and agreed not to reach the end of the trial did not participate in other clinical trials.
Exclusion criteria
Exclusion criteria: 1. There was a known allergic reaction or contraindication to the device material and its degradation product (mometasone furoate PLLA polylactic acid lactide lactide); 2. subjects need long-term oral hormones; 3. The subject is receiving immunosuppressive therapy or is known to have an immunosuppressive or autoimmune disease; 3. subjects with diabetes; 4. subjects have suffered or are suffering from glaucoma or ocular hypertension; 5. subjects with cataracts; 6. subjects with artificial eyes installed; 7. acute bacterial sinusitis and acute fungal sinusitis patients 8. expected life expectancy of subjects less than 12 months; 9. Participants in other drugs or devices clinical trials did not reach the primary end of the study 10. The subject can not or is not willing to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative intervention rate; | — |
Countries
China
Contacts
Public ContactHuide Wang
The Eye and ENT Hospital of Fudan University
Outcome results
None listed