Shanghai Chest Hospital
Shanghai, China
NCT Number: NCT07545057
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Interventional
Not applicable
Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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).
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.
Time frame: 1 year
The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline.
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.
Contact information is provided by the study sponsor or research team.
Shanghai Chest Hospital
Other
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
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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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