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NCT Number: NCT06832943

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Unicorn system

Procedure

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

Primary outcomes

  1. The success rate of stent placement

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Changhao Zhong

CONTACT

[email protected]

020-81566640

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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