UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052642 |
|---|---|
| Receipt number | R000059807 |
| Scientific Title | A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE-TIC negative of forceps biopsy |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/05/22 17:50:03 |
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Basic information
Public title
A Prospective Study on the Safety and Efficacy of Additional Ultrathin Cryobiopsy to ROSE-TIC Negative Cases of Forceps Biopsy in Peripheral Pulmonary Lesions
Acronym
Additonal cryobiopsy using an ultrathin cryoprobe to ROSE negative of forceps biopsy
Scientific Title
A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE-TIC negative of forceps biopsy
Scientific Title:Acronym
A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE negative of forceps biopsy
Region
| Japan |
Condition
Condition
Peripheral pulmonary lesions which is suspected malignancy
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the safety and histopathological diagnostic yield of additional cryobiopsy with ROSE negative forceps biopsy samples for small peripheral pulmonary lesions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (Bleeding)
Key secondary outcomes
Pathological diagnosis yield
Procedure time
Sample size of forceps biopsy and cryobiopsy
Accuracy of of rapid on-site cytologic evaluation touch imprint cytology
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
ROSE-TIC positive, group FB
Interventions/Control_2
ROSE-TIC negative group, FB+CB
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
1. Patients with peripheral pulmonary lesions <= 30 mm in diameter that require biopsy prior to management decision-making
2. 20 years old or more
3. Provision of written informed consent
Key exclusion criteria
1. Any serious medical condition to procedure bronchoscopy
2. Lesion located within one-third of the hilar ellipse as revealed by chest computed tomography
3. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting
4. A lesion near a large vessel
5. A distance < 10 mm between the visceral pleura and the central margin of the lesion
6. Prior enrolment in the trial
7. Pregnance
8. The inability to temporarily interrupt anticoagulant/antiplatelet agents
9. A bleeding tendency
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Sato |
Organization
National Organazation Hospital Okayama Medical Center
Division name
Department of Respiratory Medicine
Zip code
7011192
Address
1711-1 Tamasu Kitaku Okayama City
TEL
086-294-9911
04centersato@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Takigawa |
Organization
National Organazation Hospital Okayama Medical Center
Division name
Department of Respiratory Medicine
Zip code
701-1192
Address
1711-1 Kitaku Tamasu , Okayama City
TEL
086-294-9911
Homepage URL
tacky1024@gmail.com
Sponsor or person
Institute
NHO Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
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
Institutional Review Board, National Hospital Organization Okayama Medical Center
Address
1711-1 Kitaku Tamasu, Okayama City
Tel
086-294-9911
okmc-iec@nifty.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
| 2023 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059807
