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Robot vs. doctor: new study aims to improve lung biopsy accuracy

NCT ID NCT07277088

What the study statuses mean

This study's is highlighted.

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.
Paused
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new robot-assisted system to the standard manual method for taking a tissue sample (biopsy) from a lung nodule. The goal is to see if the robot is as safe and effective at diagnosing lung cancer or other conditions. About 158 adults with suspicious lung nodules will be randomly assigned to one of the two biopsy methods. The main focus is on how often the biopsy gives a clear diagnosis, along with procedure time and complication rates.

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 158 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 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 80 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: 1\) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation. Exclusion Criteria: 1\) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.

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Conditions

The condition(s) this trial relates to.

disease lung cancer lung neoplasm Multiple Pulmonary Nodules

As listed by the trial registrant

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

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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