UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061856 |
|---|---|
| Receipt number | R000069964 |
| Scientific Title | Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease -CRYO-DIRECTION study- |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/10 12:52:27 |
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Basic information
Public title
Safety and Efficacy of Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease
Acronym
Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease -CRYO-DIRECTION study-
Scientific Title
Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease -CRYO-DIRECTION study-
Scientific Title:Acronym
-CRYO-DIRECTION study-
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and diagnostic utility of ultrathin cryobiopsy using a 1.1-mm cryoprobe with a direct specimen retrieval technique through the therapeutic bronchoscope working channel for bronchoscopic diagnosis of ILD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (bleeding)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pulmonary lesions, such as ground-glass opacities or infiltrative shadows, identified on chest computed tomography (CT), who are scheduled to undergo ultrathin cryobiopsy using a 1.1-mm cryoprobe under a therapeutic bronchoscope to determine the treatment strategy.
Age>=20 years.
Written informed consent for participation in this study obtained from the patient.
Key exclusion criteria
Patients strongly suspected of having lung cancer based on elevated tumor markers in blood tests or imaging findings.
Lesions located in the inner one-third of the lung field from the hilum.
Patients who require additional bronchoscopic procedures other than bronchoalveolar lavage and cryobiopsy before the examination.
Lesions adjacent to major blood vessels.
Lesions in which the distance from the planned cryobiopsy site to the pleura is less than 1 cm.
Pregnant women or women who may be pregnant.
Patients receiving anticoagulant or antiplatelet therapy who cannot discontinue these medications prior to the procedure.
Patients with a marked bleeding tendency.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Takigawa |
Organization
NHO Okayama Medical Center
Division name
Department of Respiratory Medicine
Zip code
701-1192
Address
1711-1 Okayamashi Kitaku Tamasu
TEL
086-294-9911
tacky1024@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Takigawa |
Organization
NHO Okayama Medical Center
Division name
IRB
Zip code
701-1192
Address
1711-1 Okayamashi Kitaku Tamasu
TEL
086-294-9911
Homepage URL
tacky1024@gmail.com
Sponsor or person
Institute
Department of Clinical Research, National Hospital Organization Okayama Medical Center, Okayama, Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research, National Hospital Organization Okayama Medical Center, Okayama, Japan
Address
1711-1 Okayamashi Kitaku Tamasu
Tel
0862949911
tacky1024@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Observational Study
This prospective study aims to investigate the safety and diagnostic outcomes of the Direct Retrieval through the Therapeutic Bronchoscope Channel Technique , which utilizes a 1.1-mm cryoprobe for ultrathin cryobiopsy, in patients with abnormal chest imaging findings, including ground-glass opacities and pulmonary infiltrates, who undergo the procedure as part of routine clinical bronchoscopy.
Management information
Registered date
| 2026 | Year | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069964
