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

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Peripheral Pulmonary Lesion

Treatments: Procedure: unicorn robotic bronchoscopy system; Procedure: Conventional navigation bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06832930

RBS-cryobiopsy

Details and patient eligibility

About

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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion Criteria:

• Patients are eligible for inclusion if they meet all of the following criteria:

  1. Age ≥18 years and ≤75 years, with no gender restrictions;
  2. Presence of a peripheral lung lesion on chest CT
  3. Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
  4. 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:

  1. 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;

  2. Female patients who are breastfeeding, pregnant, or planning pregnancy;

  3. Patients with electromagnetic active implantable medical devices;

  4. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;

  5. 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;

  6. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

     Exclusion Criteria:

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

RBS group

Experimental group

Description:

Patients in RBS group would undergo cryobiopsy with the help of RBS

Treatment:

Procedure: unicorn robotic bronchoscopy system

Control group

Other group

Description:

Patients in control group would undergo cryobiopsy with the help of conventional navigation technology.

Treatment:

Procedure: Conventional navigation bronchoscopy