Status:
COMPLETED
Design and Application of Nasal Stents
Lead Sponsor:
Peking University Third Hospital
Conditions:
Nasal Septum; Deviation, Congenital
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Comparative study of nasal stents and nasal packing in patients undergoing septoplasty
Detailed Description
To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septopl...
Eligibility Criteria
Inclusion
- The subjects voluntarily participate in the experiment and sign the informed consent;
- Age range from 18 to 70 years old, gender unlimited;
- With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);
- No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
- No other treatment was used;
- ASA grade 1\~2;
- Able to communicate well with researchers and follow the requirements of the experiment.
Exclusion
- There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
- History of craniocerebral and nasal surgery;
- The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
- Patients known to be allergic to test instrument materials;
- Pregnant or lactating women;
- Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study;
- Participants who have participated in other clinical trials within the last 1 month;
- Participants considered unsuitable for this clinical trial for other reasons.
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05243147
Start Date
October 22 2020
End Date
August 30 2022
Last Update
May 31 2023
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191