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

Not Applicable

Not yet recruiting

• Conditions: Airway Stenosis

• Registration Number: NCT06832943
• Lead Sponsor: Guangzhou Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study Start: 2025-02-15
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients are eligible only if they fulfill all of the following criteria:

  1. Age ≥ 18 years, regardless of gender;
  2. Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;
  3. Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.

Patients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria

• Patients fulfilling any of the following criteria will be excluded from this study:

  1. Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;
  2. Apparent coagulation dysfunctions;
  3. Pregnant or lactating women, or participants with a pregnancy plan during the study period;
  4. Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;
  5. Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;
  6. Participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; Other circumstances that the investigator considers inappropriate for participation in this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The success rate of stent placement	During the bronchoscopy	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.