UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037156 |
|---|---|
| Receipt number | R000042342 |
| Scientific Title | Safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2021/10/21 23:09:31 |
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Basic information
Public title
Safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Acronym
Cryobiopsy through a nasobronchial tube
Scientific Title
Safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Scientific Title:Acronym
Cryobiopsy through a nasobronchial tube
Region
| Japan |
Condition
Condition
Lung diseases
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of thin bronchoscopic cryobiopsy through a long nasobronchial tube for lung diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Safety (frequency of bleeding)
Key secondary outcomes
1. Safety (frequency of complications other than bleeding)
2. Pathological diagnostic yield
3. Procedural duration
4. Frequency of oxygen desaturation
5. Size of specimens
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 with lung lesions on chest CT, to whom tissue sampling by cryobiopsy is considered adequate for a pathological diagnosis.
2. >=20 years old
3. Patients who can temporarily interrupt anticoagulant/antiplatelet agents
4. Informed consent
Key exclusion criteria
1. Lesion located within the inner second ellipse from the hilum on chest CT
2. Patients who were previously enrolled in this trial
3. Patients who need to undergo a bronchoscopic procedure for a nontarget lesion in the same setting
4. Patients with large lung cysts near the biopsy site
5. Lesions near a large vessel
6. Lesions inaccessible to the cryoprobe (e.g. apical lung lesions)
7. Patients with a diffuse lung disease who are receiving steroid therapy
8. Pregnant woman
9. Bleeding tendency
10. Pulmonary hypertension
11. Serious concomitant medical illness
12. Other clinical difficulties
Target sample size
80
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 460-0001, 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 460-0001, 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
None
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
The institutional review board of Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, 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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 24 | 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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042342
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
