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NCT Number: NCT07521618

One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ablation

Procedure

Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Diagnostic success rate

    Time frame: 3 days after procedure( when the pathological examination results are available)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Changhao Zhong

CONTACT

[email protected]

02081566640

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System

Acronym: One-stop

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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