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Not yet recruiting NCT06832930

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

No phase Interventional Peripheral Pulmonary Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: unicorn robotic bronchoscopy system, Conventional navigation bronchoscopy.
Who it may be relevant to
Registry conditions: Peripheral Pulmonary Lesion. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 .

Interventions

  • Procedure unicorn robotic bronchoscopy system
    cryobiopsy with the help of robotic bronchoscopy system
  • Procedure Conventional navigation bronchoscopy
    cryobiopsy with the help of Conventional navigation bronchoscopy

Primary outcome measures

  • overall diagnostic yield [Time frame: 6 months after biopsy]
Secondary outcome measures (1)
  • Navigation success rate [Time frame: During the bronchoscopy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • de Baere T, Woodrum D, Tselikas L, Abtin F, Littrup P, Deschamps F, Suh R, Aoun HD, Callstrom M. The ECLIPSE Study: Efficacy of Cryoablation on Metastatic Lung Tumors With a 5-Year Follow-Up. J Thorac Oncol. 2021 Nov;16(11):1840-1849. doi: 10.1016/j.jtho.2021.07.021. Epub 2021 Aug 9. PMID 34384914

Identifiers

NCT: NCT06832930 · RBS-cryobiopsy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗