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

NCT06832930 | Not Yet Recruiting DMC

• 1 other identifier: RBS-cryobiopsy
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Peripheral Pulmonary Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Navigation success rate

  During the bronchoscopy

Study Arms (2)

RBS group

EXPERIMENTAL

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

Procedure: unicorn robotic bronchoscopy system

Control group

OTHER

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

Procedure: Conventional navigation bronchoscopy

Interventions

unicorn robotic bronchoscopy system PROCEDURE

cryobiopsy with the help of robotic bronchoscopy system

RBS group

Conventional navigation bronchoscopy PROCEDURE

cryobiopsy with the help of Conventional navigation bronchoscopy

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

Changhao Zhong

CONTACT

020-81566640; vast1982@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: February 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02