Peripheral Pulmonary Lesions (PPLs)NCT07772479
Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions
A study testing CassiII rotational core biopsy and Automated biopsy in people with Peripheral Pulmonary Lesions (PPLs) and Pulmonary Nodules, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Pulmonary Lesions (PPLs), Pulmonary Nodules
- What is being tested?
- CassiII rotational core biopsy and Automated biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Needle Biopsy for the Diagnosis of 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.
- Being tested
- CassiII rotational core biopsy, Automated biopsy
- Keywords
- Rotational Cryobiopsy Needle, Automated Biopsy Needle, Diagnostic Yield, Peripheral Pulmonary Lesions
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CassiII rotational core biopsyProcedure or surgery
CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Automated biopsyProcedure or surgery
Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
| Study group | Role | What they receive |
|---|---|---|
| CassiII rotational core biopsy group | Experimental | Under CT guidance, a percutaneous puncture is performed using a coaxial needle; upon reaching the target lesion, the CassiII rotational core biopsy needle is inserted along the coaxial needle for biopsy. At the same lesion site, ≥1 biopsy is performed; depending on sample adequacy, the maximum number of biopsies shall not exceed 3, with at least 1 tissue specimen obtained from each biopsy. Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax. Receives: Procedure: CassiII rotational core biopsy |
| Automated biopsy needle group | Active comparator | Under CT guidance, a coaxial needle is percutaneously inserted; upon reaching the target lesion, an automated biopsy needle is advanced along the coaxial needle and activated. Biopsy is performed at least once at the same lesion site; depending on sample adequacy, the procedure may be repeated up to a maximum of 3 times, with at least one tissue specimen obtained from each attempt. Subsequently, the automated biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax. Receives: Procedure: Automated biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of the two biopsy methods
Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%
Measured: From enrollment to the end of procedure at 2 years
Secondary outcomes (3)
Specimen size
biopsy tissue size (long diameter, millimeter)
Measured: From enrollment to the end of procedure at 2 years
Consistency analysis between AI-ROSE results and pathological results
The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE
Measured: From enrollment to the end of procedure at 2 years
Safety indicators
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.
Measured: From enrollment to the end of procedure at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary Lesions (PPLs)Studies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employed a prospective, randomized, single-blind, parallel-group, single-center trial design, enrolling consecutive patients with peripheral pulmonary nodules of unknown etiology. The subjects were randomly assigned (1:1) to either the CassiII rotational core biopsy group (experimental group) or the automated biopsy needle group (control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772479
- Sponsor's protocol ID
- 2025-ke-1100-1
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie S, Ju S, Zhang X, Qi C, Zhang J, Mao M, Chen C, Chen Y, Ji F, Zhou J, Wang L. A retrospective comparative study on the diagnostic efficacy and the complications: between CassiII rotational core biopsy and core needle biopsy. Front Oncol. 2023 Sep 26;13:1067246. doi: 10.3389/fonc.2023.1067246. eCollection 2023.
PubMed 37823052Yeow KM, Su IH, Pan KT, Tsay PK, Lui KW, Cheung YC, Chou AS. Risk factors of pneumothorax and bleeding: multivariate analysis of 660 CT-guided coaxial cutting needle lung biopsies. Chest. 2004 Sep;126(3):748-54. doi: 10.1378/chest.126.3.748.
PubMed 15364752Tai R, Dunne RM, Trotman-Dickenson B, Jacobson FL, Madan R, Kumamaru KK, Hunsaker AR. Frequency and Severity of Pulmonary Hemorrhage in Patients Undergoing Percutaneous CT-guided Transthoracic Lung Biopsy: Single-Institution Experience of 1175 Cases. Radiology. 2016 Apr;279(1):287-96. doi: 10.1148/radiol.2015150381. Epub 2015 Oct 19.
PubMed 26479161Vachani A, Zhou M, Ghosh S, Zhang S, Szapary P, Gaurav D, Kalsekar I. Complications After Transthoracic Needle Biopsy of Pulmonary Nodules: A Population-Level Retrospective Cohort Analysis. J Am Coll Radiol. 2022 Oct;19(10):1121-1129. doi: 10.1016/j.jacr.2022.04.010. Epub 2022 Jun 20.
PubMed 35738412Yoon SH, Park CM, Lee KH, Lim KY, Suh YJ, Im DJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Hong H. Analysis of Complications of Percutaneous Transthoracic Needle Biopsy Using CT-Guidance Modalities In a Multicenter Cohort of 10568 Biopsies. Korean J Radiol. 2019 Feb;20(2):323-331. doi: 10.3348/kjr.2018.0064.
PubMed 30672172Balasubramanian P, Abia-Trujillo D, Barrios-Ruiz A, Garza-Salas A, Koratala A, Chandra NC, Yu Lee-Mateus A, Labarca G, Fernandez-Bussy S. Diagnostic yield and safety of diagnostic techniques for pulmonary lesions: systematic review, meta-analysis and network meta-analysis. Eur Respir Rev. 2024 Sep 18;33(173):240046. doi: 10.1183/16000617.0046-2024. Print 2024 Jul.
PubMed 39293856Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, Eguchi K, Kuriyama K, Sakai F, Noguchi M, Murata K, Murayama S, Mochizuki T, Mori K, Yamada K. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol. 2006 Jul;59(1):60-4. doi: 10.1016/j.ejrad.2006.02.001. Epub 2006 Mar 10.
PubMed 16530369Wiener RS, Schwartz LM, Woloshin S, Welch HG. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. 2011 Aug 2;155(3):137-44. doi: 10.7326/0003-4819-155-3-201108020-00003.
PubMed 21810706Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
PubMed 27108299Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Pneumothorax rates in CT-Guided lung biopsies: a comprehensive systematic review and meta-analysis of risk factors. Br J Radiol. 2020 Apr 1;93(1108):20190866. doi: 10.1259/bjr.20190866. Epub 2020 Jan 3.
PubMed 31860329Tachibana K, Nakazato Y, Tsuchida S, Kazama T, Minato K, Yoshida T, Fujita A, Horikoshi H, Tanaka R, Iijima M, Goya T. Immediate cytology improves accuracy and decreases complication rate in real-time computed tomography-guided needle lung biopsy. Diagn Cytopathol. 2013 Dec;41(12):1063-8. doi: 10.1002/dc.22940. Epub 2012 Dec 14.
PubMed 23239643Yamagami T, Yoshimatsu R, Miura H, Yamada K, Takahata A, Matsumoto T, Hasebe T. Diagnostic performance of percutaneous lung biopsy using automated biopsy needles under CT-fluoroscopic guidance for ground-glass opacity lesions. Br J Radiol. 2013 Feb;86(1022):20120447. doi: 10.1259/bjr.20120447.
PubMed 23385998Zhang L, Shi L, Xiao Z, Qiu H, Peng P, Zhang M. Coaxial technique-promoted diagnostic accuracy of CT-guided percutaneous cutting needle biopsy for small and deep lung lesions. PLoS One. 2018 Feb 15;13(2):e0192920. doi: 10.1371/journal.pone.0192920. eCollection 2018.
PubMed 29447239Kothary N, Lock L, Sze DY, Hofmann LV. Computed tomography-guided percutaneous needle biopsy of pulmonary nodules: impact of nodule size on diagnostic accuracy. Clin Lung Cancer. 2009 Sep;10(5):360-3. doi: 10.3816/CLC.2009.n.049.
PubMed 19808195Yeow KM, Tsay PK, Cheung YC, Lui KW, Pan KT, Chou AS. Factors affecting diagnostic accuracy of CT-guided coaxial cutting needle lung biopsy: retrospective analysis of 631 procedures. J Vasc Interv Radiol. 2003 May;14(5):581-8. doi: 10.1097/01.rvi.0000071087.76348.c7.
PubMed 12761311
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT07772479
- Acronym / sponsor ID
- 2025-ke-1100-1
- Keywords
- Rotational Cryobiopsy Needle, Automated Biopsy Needle, Diagnostic Yield, Peripheral Pulmonary Lesions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study employed a prospective, randomized, single-blind, parallel-group, single-center trial design, enrolling consecutive patients with peripheral pulmonary nodules of unknown etiology. The subjects were randomly assigned (1:1) to either the CassiII rotational core biopsy group (experimental group) or the automated biopsy needle group (control group).
| Arm | Type | Receives |
|---|---|---|
| CassiII rotational core biopsy group | Experimental | Procedure: CassiII rotational core biopsyUnder CT guidance, a percutaneous puncture is performed using a coaxial needle; upon reaching the target lesion, the CassiII rotational core biopsy needle is inserted along the coaxial needle for biopsy. At the same lesion site, ≥1 biopsy is performed; depending on sample adequacy, the maximum number of biopsies shall not exceed 3, with at least 1 tissue specimen obtained from each biopsy. Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax. |
| Automated biopsy needle group | Active comparator | Procedure: Automated biopsyUnder CT guidance, a coaxial needle is percutaneously inserted; upon reaching the target lesion, an automated biopsy needle is advanced along the coaxial needle and activated. Biopsy is performed at least once at the same lesion site; depending on sample adequacy, the procedure may be repeated up to a maximum of 3 times, with at least one tissue specimen obtained from each attempt. Subsequently, the automated biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- Severe cardiopulmonary dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CassiII rotational core biopsyCassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed. | Procedure or surgery | CassiII rotational core biopsy group |
| Automated biopsyAutomated biopsy needle is inserted in lesion site, ≥1 biopsy is performed. | Procedure or surgery | Automated biopsy needle group |
Primary outcome
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%
3 secondary outcomes
Specimen size
Time frame: From enrollment to the end of procedure at 2 years
Consistency analysis between AI-ROSE results and pathological results
Time frame: From enrollment to the end of procedure at 2 years
Safety indicators
Time frame: From enrollment to the end of procedure at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 37823052Xie S, Ju S, Zhang X, Qi C, Zhang J, Mao M, Chen C, Chen Y, Ji F, Zhou J, Wang L. A retrospective comparative study on the diagnostic efficacy and the complications: between CassiII rotational core biopsy and core needle biopsy. Front Oncol. 2023 Sep 26;13:1067246. doi: 10.3389/fonc.2023.1067246. eCollection 2023.
- Results publication: PubMed 15364752Yeow KM, Su IH, Pan KT, Tsay PK, Lui KW, Cheung YC, Chou AS. Risk factors of pneumothorax and bleeding: multivariate analysis of 660 CT-guided coaxial cutting needle lung biopsies. Chest. 2004 Sep;126(3):748-54. doi: 10.1378/chest.126.3.748.
- Results publication: PubMed 26479161Tai R, Dunne RM, Trotman-Dickenson B, Jacobson FL, Madan R, Kumamaru KK, Hunsaker AR. Frequency and Severity of Pulmonary Hemorrhage in Patients Undergoing Percutaneous CT-guided Transthoracic Lung Biopsy: Single-Institution Experience of 1175 Cases. Radiology. 2016 Apr;279(1):287-96. doi: 10.1148/radiol.2015150381. Epub 2015 Oct 19.
- Results publication: PubMed 35738412Vachani A, Zhou M, Ghosh S, Zhang S, Szapary P, Gaurav D, Kalsekar I. Complications After Transthoracic Needle Biopsy of Pulmonary Nodules: A Population-Level Retrospective Cohort Analysis. J Am Coll Radiol. 2022 Oct;19(10):1121-1129. doi: 10.1016/j.jacr.2022.04.010. Epub 2022 Jun 20.
- Results publication: PubMed 30672172Yoon SH, Park CM, Lee KH, Lim KY, Suh YJ, Im DJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Hong H. Analysis of Complications of Percutaneous Transthoracic Needle Biopsy Using CT-Guidance Modalities In a Multicenter Cohort of 10568 Biopsies. Korean J Radiol. 2019 Feb;20(2):323-331. doi: 10.3348/kjr.2018.0064.
- Results publication: PubMed 39293856Balasubramanian P, Abia-Trujillo D, Barrios-Ruiz A, Garza-Salas A, Koratala A, Chandra NC, Yu Lee-Mateus A, Labarca G, Fernandez-Bussy S. Diagnostic yield and safety of diagnostic techniques for pulmonary lesions: systematic review, meta-analysis and network meta-analysis. Eur Respir Rev. 2024 Sep 18;33(173):240046. doi: 10.1183/16000617.0046-2024. Print 2024 Jul.
- Results publication: PubMed 16530369Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, Eguchi K, Kuriyama K, Sakai F, Noguchi M, Murata K, Murayama S, Mochizuki T, Mori K, Yamada K. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol. 2006 Jul;59(1):60-4. doi: 10.1016/j.ejrad.2006.02.001. Epub 2006 Mar 10.
- Results publication: PubMed 21810706Wiener RS, Schwartz LM, Woloshin S, Welch HG. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. 2011 Aug 2;155(3):137-44. doi: 10.7326/0003-4819-155-3-201108020-00003.
- Results publication: PubMed 27108299Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
- Results publication: PubMed 31860329Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Pneumothorax rates in CT-Guided lung biopsies: a comprehensive systematic review and meta-analysis of risk factors. Br J Radiol. 2020 Apr 1;93(1108):20190866. doi: 10.1259/bjr.20190866. Epub 2020 Jan 3.
- Results publication: PubMed 23239643Tachibana K, Nakazato Y, Tsuchida S, Kazama T, Minato K, Yoshida T, Fujita A, Horikoshi H, Tanaka R, Iijima M, Goya T. Immediate cytology improves accuracy and decreases complication rate in real-time computed tomography-guided needle lung biopsy. Diagn Cytopathol. 2013 Dec;41(12):1063-8. doi: 10.1002/dc.22940. Epub 2012 Dec 14.
- Results publication: PubMed 23385998Yamagami T, Yoshimatsu R, Miura H, Yamada K, Takahata A, Matsumoto T, Hasebe T. Diagnostic performance of percutaneous lung biopsy using automated biopsy needles under CT-fluoroscopic guidance for ground-glass opacity lesions. Br J Radiol. 2013 Feb;86(1022):20120447. doi: 10.1259/bjr.20120447.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CassiII rotational core biopsy and Automated biopsy in people with Peripheral Pulmonary Lesions (PPLs) and Pulmonary Nodules, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of the two biopsy methods (time frame: From enrollment to the end of procedure at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07772479, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.