Not yet recruiting NCT07521618
One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation
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: Ablation.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Suspected or Confirmed), Cryoablation, Robotic Bronchoscopy System, Confocal Laser Endomicroscopy. Basic parameters: from 18 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 →
Unsure about the terms? Read our patient guide →
Official title
An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System
Overview
Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.
Interventions
- Procedure Ablation
Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer
Primary outcome measures
- Integrated completion rate of detection, sampling and treatment [Time frame: Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)]
Secondary outcome measures (1)
- Diagnostic success rate [Time frame: 3 days after procedure( when the pathological examination results are available)]
Eligibility criteria
Inclusion criteria
- Age ≥18 years, male or female.
- High-risk pulmonary nodule/tumor maximum diameter ≤3 cm.
- Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.
- Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.
Exclusion criteria
- Diffuse bilateral lung lesions unresponsive to ablation.
- Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy.
- Severe bleeding tendency or irreversible coagulopathy (PT >18 s, PTA <40%).Platelet count <70×10⁹/L; anticoagulant/antiplatelet therapy discontinued <1 week before ablation (except prophylactic low-molecular-weight heparin).
- Severe pulmonary impairment (maximal voluntary ventilation <40%).
- Other metastatic tumors with widespread metastasis; life expectancy <3 months.
- Poor general condition: widespread metastasis, severe infection, high fever, infectious/radiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic/nutritional disorders.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- Target lesion received radiotherapy within the past 6 months.
- Active hepatitis B, active hepatitis C, known HIV-1/2 antibody positivity, or other active infections judged by the investigator to interfere with treatment.
- History of epilepsy, psychosis, or cognitive impairment.
- Pregnant/lactating females; males or females planning conception during the trial.
- Other conditions deemed inappropriate by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- You Z, Huang J, Wang F, Xu L, Liu J, Li H, Tang J, Li W, Li Z, Liu Y, Bai Y, Li S, Zhong C. Dual-correction robotic bronchoscopy system with ultra-thin catheter for diagnosing challenging peripheral pulmonary nodules: A multi-centre prospective trial. Pulmonology. 2026 Dec;32(1):2621546. doi: 10.1080/25310429.2026.2621546. Epub 2026 Feb 4. PMID 41635252
- Xie F, Zhang Q, Mu C, Zhang Q, Yang H, Mao J, Simoff MJ, Huang J, Zhang X, Sun J. Shape-sensing Robotic-assisted Bronchoscopy (SS-RAB) in Sampling Peripheral Pulmonary Nodules: A Prospective, Multicenter Clinical Feasibility Study in China. J Bronchology Interv Pulmonol. 2024 Aug 8;31(4):e0981. doi: 10.1097/LBR.0000000000000981. eCollection 2024 Oct 1. PMID 39115240
Identifiers
NCT: NCT07521618 · CLE-RBS-Ablation · 2022YFC2405200