Skip to main content
OpenTrials
Enrolling by invitation

NCT Number: NCT07772479

Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions

This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique(CassiII rotational core biopsy) versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.

Enrolling by invitation

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital

Beijing, Chaoyang, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CassiII rotational core biopsy

Procedure

CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.

Automated biopsy

Procedure

Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.

Primary outcomes

  1. Diagnostic yield of the two biopsy methods

    Time frame: From enrollment to the end of procedure at 2 years

    Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%

Secondary outcomes

  1. Specimen size

    Time frame: From enrollment to the end of procedure at 2 years

    biopsy tissue size (long diameter, millimeter)

  2. Consistency analysis between AI-ROSE results and pathological results

    Time frame: From enrollment to the end of procedure at 2 years

    The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE

  3. Safety indicators

    Time frame: From enrollment to the end of procedure at 2 years

    Complications: Incidence (including pneumothorax, hemorrhage, respiratory failure, infection, and severe complications requiring endotracheal intubation and mechanical ventilation to be transferred to the Intensive Care Unit), severity levels, and corresponding management measures.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Lesions

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.