Lung Cancer (Suspected or Confirmed)One-stopNCT07521618
One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation
A study testing Ablation in people with Lung Cancer (Suspected or Confirmed) and Cryoablation, run by Guangzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Suspected or Confirmed), Cryoablation, Robotic Bronchoscopy System
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System
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.
- Conditions
- Lung Cancer (Suspected or Confirmed), Cryoablation, Robotic Bronchoscopy System, Confocal Laser Endomicroscopy
- Being tested
- Ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer
| Study group | Role | What they receive |
|---|---|---|
| One-stop group | Experimental | Using RBS, nCLE, r-EBUS, OBCT and ablation Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated completion rate of detection, sampling and treatment
Integrated completion rate of detection, sampling and treatment= (Number of cases with successful integrated detection, sampling and treatment / Total enrolled cases) × 100% Definition of integrated success: Under the guidance of the bronchial navigation and positioning system, the lesion is confirmed by radial endobronchial ultrasound (r-EBUS) or CBCT; imaging diagnosis is obtained via probe-based confocal laser endomicroscopy (pCLE); qualified tissue samples are successfully collected; and local treatment is completed.
Measured: Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)
Secondary outcomes (1)
Diagnostic success rate
Diagnostic success rate
= (Number of cases with definite pathological diagnosis / Total enrolled cases) × 100%
Definition of definite pathological diagnosis:
Malignant lesions Specific benign lesions: tuberculosis, fungal infection, granulomatous lesions, organizing pneumonia, etc.
Measured: 3 days after procedure( when the pathological examination results are available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Suspected or Confirmed)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyue, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521618
- Sponsor's protocol ID
- CLE-RBS-Ablation
- Other IDs
- 2022YFC2405200
- Acronym
- One-stop
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41635252Xie 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.
PubMed 39115240