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

April 8, 2026 updated by: Li Shiyue, Guangzhou Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One-stop group
Using RBS, nCLE, r-EBUS, OBCT and ablation
Procedure: Ablation
Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days after procedure( when the pathological examination results are available)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLE-RBS-Ablation
  • 2022YFC2405200 (Other Grant/Funding Number: National Key Research and Development Program of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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