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

NCT ID: NCT06832943

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RBS group

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

Group Type: EXPERIMENTAL

Unicorn system

Intervention Type: PROCEDURE

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

Interventions

Unicorn system

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Li Shiyue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Changhao Zhong

Role: CONTACT

vast1982@126.com

020-81566640

Other Identifiers

RBS-Stent

Identifier Type: -

Identifier Source: org_study_id