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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Pulmonary Lesion
• Intervention / Treatment: Procedure: unicorn robotic bronchoscopy system; Procedure: Conventional navigation bronchoscopy

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Changhao Zhong; Phone Number: 020-81566640; Email: vast1982@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RBS group; Patients in RBS group would undergo cryobiopsy with the help of RBS	Procedure: unicorn robotic bronchoscopy system; cryobiopsy with the help of robotic bronchoscopy system
Other: Control group; Patients in control group would undergo cryobiopsy with the help of conventional navigation technology.	Procedure: Conventional navigation bronchoscopy; cryobiopsy with the help of Conventional navigation bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall diagnostic yield	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.	6 months after biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navigation success rate	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.	During the bronchoscopy

Collaborators and Investigators

• Sponsor: Guangzhou Medical University

Publications and helpful links

General 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. Erratum In: J Thorac Oncol. 2021 Nov 3:S1556-0864(21)03251-2. doi: 10.1016/j.jtho.2021.10.006.

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RBS-cryobiopsy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No