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

NCT06832943 | Not Yet Recruiting DMC

• 1 other identifier: RBS-Stent
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Stenosis

Outcome Measures

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.

  During the bronchoscopy

Study Arms (1)

RBS group

EXPERIMENTAL

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

Procedure: Unicorn system

Interventions

Unicorn system PROCEDURE

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

RBS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients fulfilling any of the following criteria will be excluded from this study:
• 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;
• Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;
• 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.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Central Study Contacts

Changhao Zhong

CONTACT

020-81566640; vast1982@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: February 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share