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Robotic scope could biopsy and burn lung nodules in one go

NCT ID NCT07545057

Disease control Sponsor: Shanghai Chest Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether a robot-assisted bronchoscope can safely take a tissue sample (biopsy) and then immediately destroy a suspicious lung nodule using heat (radiofrequency ablation) in a single procedure. About 76 adults with small, early-stage lung nodules who cannot or will not have surgery will participate. The goal is to see if this combined approach is technically successful and provides a less invasive treatment option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Multiple Pulmonary Nodules

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary nodules Pulmonary nodules suspected to be malignant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Chest Hospital

    Shanghai, China

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