The Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Unicorn system

    Procedure/Surgery

    Patients with airway stenosis undergo stent placement with the help of RBS.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: RBS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During the bronchoscopy

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: