About this trial
The primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, regardless of gender;
Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;
Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.
Disqualifiers
Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;
Apparent coagulation dysfunctions;
Pregnant or lactating women, or participants with a pregnancy plan during the study period;
Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;
Trial design
Single group
Treatments tested in this trial
Unicorn system
Procedure/SurgeryPatients with airway stenosis undergo stent placement with the help of RBS.
Treatment groups
Trial outcomes
Primary outcomes
The success rate of stent placement
The success rate of stent placement = (The number of patients with successful stent placement / The number of patients undergoing stent placement surgery) × 100% Successful placement: The stent is placed in the appropriate position without displacement, and the upper and lower ends of the stent are unobstructed.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: