Pulmonary LesionNCT07352176
Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions
A study testing Confocal laser endomicroscopy combined cryobiopsy and Conventional cryobiopsy in people with Pulmonary Lesion and Lung Cancer, run by Guangzhou Medical University at 1 site in China.
Trial summary
Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Lesion, Lung Cancer
- What is being tested?
- Confocal laser endomicroscopy combined cryobiopsy and Conventional cryobiopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old with lung lesions indicated by chest CT;
- Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
- Able to understand and voluntarily sign the written informed consent form. -
Who cannot join
- Patients with contraindications to anesthesia or bronchoscopy;
- Patients with uncorrectable coagulation disorders;
- Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
- Patients with severe liver or kidney dysfunction, mental illness, etc.;
- Pregnant or lactating patients;
- Patients without a clear histological or clinical diagnosis;
- Subjects deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, Guangdong, 510100
About this study
Official title: Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions
Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.
- Conditions
- Pulmonary Lesion, Lung Cancer
- Being tested
- Confocal laser endomicroscopy combined cryobiopsy, Conventional cryobiopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopy combined cryobiopsyOther
Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.
Conventional cryobiopsyOther
Patients in the conventional group will underg cryobiopsy for lung lesions.
| Study group | Role | What they receive |
|---|---|---|
| Diffuse- Conventional Group | Active comparator | The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions. Receives: Other: Conventional cryobiopsy |
| Diffuse- Combined Group | Experimental | The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions Receives: Other: Confocal laser endomicroscopy combined cryobiopsy |
| Localized - Convention Group | Active comparator | The Localized-Conventional Group used conventional cryobiopsy for lung lesions. Receives: Other: Conventional cryobiopsy |
| Localized - Combined Group | Experimental | The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions Receives: Other: Confocal laser endomicroscopy combined cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The Incidence of adverse events = (the number of adverse event / the number of procedures) * 100%
Measured: 7 days after procedure
Secondary outcomes (2)
Diagnostic yield
The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) * 100%
Measured: Immediately after the procedure
Hole-in-lesion rate
The rate of "hole-in-lesion" = (The number of cases with "hole-in-lesion" / The total number of cases that completed biopsy) * 100% The definition of "Hole-in-lesion": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary LesionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyue, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352176
- Sponsor's protocol ID
- CLE-Cryo
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25.
PubMed 34172559Wellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19.
PubMed 26094505Sorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9.
PubMed 24909555
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT07352176
- Acronym / sponsor ID
- CLE-Cryo
- Conditions
- Pulmonary Lesion, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 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.
Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diffuse- Conventional Group | Active comparator | Other: Conventional cryobiopsyThe Diffuse-Conventional Group used conventional cryobiopsy for lung lesions. |
| Diffuse- Combined Group | Experimental | Other: Confocal laser endomicroscopy combined cryobiopsyThe Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions |
| Localized - Convention Group | Active comparator | Other: Conventional cryobiopsyThe Localized-Conventional Group used conventional cryobiopsy for lung lesions. |
| Localized - Combined Group | Experimental | Other: Confocal laser endomicroscopy combined cryobiopsyThe Localized-Combined Group used CLE combined with cryobiopsy for lung lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old with lung lesions indicated by chest CT;
- Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
- Able to understand and voluntarily sign the written informed consent form. -
Key exclusion criteria (7 listed)
- Patients with contraindications to anesthesia or bronchoscopy;
- Patients with uncorrectable coagulation disorders;
- Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
- Patients with severe liver or kidney dysfunction, mental illness, etc.;
- Pregnant or lactating patients;
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 |
|---|---|---|
| Confocal laser endomicroscopy combined cryobiopsyPatients in the combined group will undergo CLT combined with cryobiopsy for lung lesions. | Other | Diffuse- Combined Group, Localized - Combined Group |
| Conventional cryobiopsyPatients in the conventional group will underg cryobiopsy for lung lesions. | Other | Diffuse- Conventional Group, Localized - Convention Group |
Primary outcome
Incidence of adverse events
Time frame: 7 days after procedure
The Incidence of adverse events = (the number of adverse event / the number of procedures) * 100%
2 secondary outcomes
Diagnostic yield
Time frame: Immediately after the procedure
Hole-in-lesion rate
Time frame: During the procedure
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 20 Jan 2026.
- Background: PubMed 34172559Kramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25.
- Background: PubMed 26094505Wellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19.
- Background: PubMed 24909555Sorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9.
- Individual participant dataSharing planned: Undecided
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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 Confocal laser endomicroscopy combined cryobiopsy and Conventional cryobiopsy in people with Pulmonary Lesion and Lung Cancer, run by Guangzhou Medical University 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Jan 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?
Incidence of adverse events (time frame: 7 days after procedure). 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 NCT07352176, which also lists 3 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 20 Jan 2026.