Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06832930

A Real-World Case Study Evaluating the Efficacy and Safety of RBS Cryobiopsy

The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are:

Does RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes.

Participants will:

Provide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion.

Be monitored for immediate and delayed complications .

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

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

  • Inclusion Criteria:
  • Patients are eligible for inclusion if they meet all of the following criteria:
  • Age ≥18 years and ≤75 years, with no gender restrictions;
  • Presence of a peripheral lung lesion on chest CT
  • Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
  • patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.

Exclusion criteria

  • Patients who meet any of the following criteria will be excluded from this study:
  • Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
  • Female patients who are breastfeeding, pregnant, or planning pregnancy;
  • Patients with electromagnetic active implantable medical devices;
  • Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
  • Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
  • Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Exclusion criteria

Treatment and study plan

unicorn robotic bronchoscopy system

Procedure

cryobiopsy with the help of robotic bronchoscopy system

Conventional navigation bronchoscopy

Procedure

cryobiopsy with the help of Conventional navigation bronchoscopy

Primary outcomes

  1. overall diagnostic yield

    Time frame: 6 months after biopsy

    Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.

Secondary outcomes

  1. Navigation success rate

    Time frame: During the bronchoscopy

    The success rate of navigation = (the number of lesions judged as successfully navigated / the total number of lesions undergoing transbronchial lung biopsy) * 100%. The criteria for judging successful navigation: if the lesion edge is confirmed by imaging equipment and the researcher deems it feasible for biopsy, it is considered a successful navigation; otherwise, it is regarded as a failed navigation. For those with a clear diagnosis through the research procedure, all are considered successful navigation.

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 Real-World Case Study Evaluating the Efficacy and Safety of Bronchial Navigation Localization Device-Assisted Cryobiopsy

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.

Published trials that share one or more normalized conditions with this study.