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

A Prospective Multicenter Single-Arm Trial Evaluating the Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Stenosis
• Intervention / Treatment: Procedure: Unicorn system

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Changhao Zhong; Phone Number: 020-81566640; Email: vast1982@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RBS group; Patients with airway stenosis undergo stent placement with the help of RBS.	Procedure: Unicorn system; Patients with airway stenosis undergo stent placement with the help of RBS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the bronchoscopy

Collaborators and Investigators

• Sponsor: Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: RBS-Stent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No