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Can a freezing needle outperform standard biopsy for lung nodules?

NCT ID NCT07772479

Diagnosis Sponsor: Beijing Chao Yang Hospital Source: ClinicalTrials.gov ↗

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial compares two biopsy techniques for diagnosing peripheral lung nodules: a newer rotational cryobiopsy needle versus the standard automated biopsy needle. About 308 participants with lung nodules (8–30 mm) will undergo CT-guided biopsy with one of the two needles. The study measures how often each method yields a correct diagnosis, the quality and size of the tissue sample, and complication rates. The goal is to determine which approach is more reliable and safer for guiding treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CassiII rotational core biopsy needle (cryobiopsy) compared with an automated biopsy needle
What this could lead to
If the cryobiopsy needle proves more accurate and safer, it could become the preferred method for diagnosing lung nodules, reducing repeat procedures.
What could go wrong
This is a comparative study, not a guarantee of superiority. The cryobiopsy needle may not outperform the standard needle, and biopsy procedures carry risks like bleeding or collapsed lung.

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 308 people

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

Started

Mar 2025

Expected to finish

Dec 2029

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 90 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: * If a chest CT scan reveals pulmonary nodules with an unknown nature, a biopsy is required for definitive diagnosis; if the chest CT shows multiple pulmonary nodules, one of these nodules should be selected as the target lesion; * Axial chest CT imaging demonstrates peripheral pulmonary nodules located in the pulmonary region, with diameters ranging from 8 mm to 30 mm; ③Voluntarily undergo CT-guided lung puncture biopsy and meet all preoperative requirements; ④Participants demonstrate good compliance, are able to cooperate with the study observations, are fully informed about the study's objectives and methods, acknowledge the potential risks, agree to participate in the study, and sign the informed consent form. Exclusion Criteria: * Severe cardiopulmonary dysfunction; * Irreversible coagulation disorders; * Suspected vascular lesions or arteriovenous malformations (assessed by contrast-enhanced CT), or presence of bronchial artery penetration at the planned biopsy site, or suspected pulmonary metastasis from renal cell carcinoma, indicating a high risk of hemorrhage; * PET-CT findings indicate a malignant pulmonary nodule; surgical evaluation may prioritize surgical intervention for the patient; * Pregnant or lactating women; ⑥ Patients with psychiatric disorders or those unable to cooperate during the puncture procedure; ⑦ Presence of anesthesia contraindications; allergy to anesthetic agents; or a history of multiple severe allergies or hereditary allergies; * If the participant has participated in other studies within the past three months without withdrawing or completing those studies, this will affect the observation of the present study; ⑨ Refusal to participate in this study, unwillingness to accept the follow-up protocol, or other circumstances in which the investigator deems the participant unsuitable for participation 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.

Peripheral pulmonary lesions (PPLS) Pulmonary nodules

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Beijing Chaoyang Hospital

    Beijing, Chaoyang, 100020, China

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