UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050606 |
|---|---|
| Receipt number | R000057640 |
| Scientific Title | A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2023/03/23 22:25:50 |
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Basic information
Public title
A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation
Acronym
Cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to assess endobronchial lesions
Scientific Title
A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation
Scientific Title:Acronym
Cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to assess endobronchial lesions
Region
| Japan |
Condition
Condition
Endotracheal or endobronchial lesions
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope, to evaluate endobronchial lesions in patients under conscious sedation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1. Safety (bleeding-related)
Key secondary outcomes
1. Safety (other than bleeding-related)
2. Histological diagnostic yield
3. Procedure duration
4. Specimen size
5. Sampling success in terms of the freezing time
6. Biomarker test success rate
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
1. Patients under conscious sedation will undergo cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions
2. 20 years old or more
3. Provision of written informed consent
Key exclusion criteria
1. Any serious, concomitant medical condition
2. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting
3. Prior enrolment in the trial
4. Patients for whom a therapeutic bronchoscope and a 1.1-mm cryoprobe were not used
5. Pregnancy
6. The inability to temporarily interrupt anticoagulant/antiplatelet agents
7. A bleeding tendency
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Oki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
masahideo@gmail.com
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Oki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
Homepage URL
masahideo@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
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 Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Japan
Tel
052-951-1111
311-rec@mail.hosp.go.jp
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
国立病院機構名古屋医療センター (愛知県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 17 | 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
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057640
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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