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NCT Number: NCT07545057

Robotic-Assisted Bronchoscopy-Guided Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules

This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old;
  • Chest CT indicates pulmonary nodules, highly suspected of being malignant;
  • Size of pulmonary nodules: 8 mm < maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3;
  • Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0);
  • Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent;
  • The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form.

Exclusion criteria

  • Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons;
  • The target nodule has been diagnosed as a malignant tumor or metastasis;
  • Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count < 50×10^9 /L, prothrombin time > 18s, prothrombin activity < 40%);
  • Severe pulmonary fibrosis and pulmonary hypertension;
  • Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery;
  • Implanted cardiac pacemaker, defibrillator, or other electronic implants;
  • Presence of important blood vessels that cannot be avoided along the biopsy path;
  • Other conditions that the investigators consider not suitable for the patient to participate in this study.

Treatment and study plan

Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules

Procedure

All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. All procedures are performed under the guidance of shape-sensing robotic-assisted bronchoscopy integrated with mobile cone-beam computed tomography. Cyobiopsy is performed first using the 1.1-mm cryoprobe, followed by intraoperative frozen section for rapid diagnosis. If malignancy is confirmed, radiofrequency ablation is conducted in the same procedure.

Primary outcomes

  1. Technical success rate (at the lesion level)

    Time frame: 6 months

    The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant.

Secondary outcomes

  1. Biopsy diagnostic yield (at the lesion level)

    Time frame: 6 months

    The proportion of lesions with a definite malignant or specific benign diagnosis by biopsy among all the lesions undergoing biopsy, evaluated by the pathological diagnosis.

  2. Sensitivity of malignancy (at the lesion level)

    Time frame: 6 months

    The proportion of lesions with a definite malignant diagnosis by biopsy among all the lesions confirmed to be malignant by the gold standard of pathology, evaluated by the pathological diagnosis.

  3. Complete ablation rate (at the lesion level)

    Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years

    The proportion of completely ablated lesions after ablation treatment among all the lesions undergoing ablation treatment, evaluated at 3 months, 1 year, 2 years, 3 years, and 5 years, respectively.

  4. Local progression-free period (at the lesion level)

    Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years

    The time from when the patient receives treatment until the target lesion shows local progression.

  5. Progression-free survival

    Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years

    The time from the patient receiving treatment until tumor progression or death from any cause (whichever occurs first).

  6. Overall survival

    Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years

    The time from the patient receiving treatment until death from any cause.

  7. Pulmonary function indicators (at the patient level)

    Time frame: 1 year

    The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline.

  8. The incidence of procedure-related complications (at the patient level)

    Time frame: 1 month

    The incidence of device- or ablation-related adverse events during the operation and within 1 month after the operation, graded according to the CTCAE v6.0 criteria, with bleeding additionally evaluated using the Nashville Delphi (2020) scale.

Study contacts

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

Jiayuan Sun, MD, PhD

CONTACT

[email protected]

86-021-22200000 ext. 1511

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

A Feasibility Study on Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules Under Robotic-Assisted Bronchoscopy: A Prospective, Single-Arm, Open-Label Clinical Study:ROBUST Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 28, 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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