An interventional study of Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules in Pulmonary Nodules, sponsored by Shanghai Chest Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
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.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 76 is below the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules
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.
Technical success rate (at the lesion level)
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
Biopsy diagnostic yield (at the lesion level)
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
Sensitivity of malignancy (at the lesion level)
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: 6 months
Complete ablation rate (at the lesion level)
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
Local progression-free period (at the lesion level)
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
Progression-free survival
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
Overall survival
The time from the patient receiving treatment until death from any cause.
Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years
Pulmonary function indicators (at the patient level)
The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline.
Time frame: 1 year
The incidence of procedure-related complications (at the patient level)
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.
Time frame: 1 month
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.