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

NCT ID: NCT06832930

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

RBS group

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

Group Type: EXPERIMENTAL

unicorn robotic bronchoscopy system

Intervention Type: PROCEDURE

cryobiopsy with the help of robotic bronchoscopy system

Control group

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

Group Type: OTHER

Conventional navigation bronchoscopy

Intervention Type: PROCEDURE

cryobiopsy with the help of Conventional navigation bronchoscopy

Interventions

unicorn robotic bronchoscopy system

cryobiopsy with the help of robotic bronchoscopy system

Intervention Type: PROCEDURE

Conventional navigation bronchoscopy

cryobiopsy with the help of Conventional navigation bronchoscopy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Li Shiyue

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Changhao Zhong

Role: CONTACT

vast1982@126.com

020-81566640

References

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.

Reference Type: BACKGROUND

PMID: 34384914 (View on PubMed)

Other Identifiers

RBS-cryobiopsy

Identifier Type: -

Identifier Source: org_study_id