UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054514 |
|---|---|
| Receipt number | R000062285 |
| Scientific Title | Prospective Study of The Lateral Decubitus Position Computed Tomography Images for Virtual Navigation |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/26 12:08:35 |
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Basic information
Public title
Prospective Study of The Lateral Decubitus Position Computed Tomography Images for Virtual Navigation
Acronym
Prospective Study of The Lateral Decubitus Position Computed Tomography Images for Virtual Navigation
Scientific Title
Prospective Study of The Lateral Decubitus Position Computed Tomography Images for Virtual Navigation
Scientific Title:Acronym
Prospective Study of The Lateral Decubitus Position Computed Tomography Images for Virtual Navigation
Region
| Japan |
Condition
Condition
Peripheral pulmonary lesions which is suspected malignancy
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluationg VBN using CT imaging can improve the determination of the optimal bronchial pathway for the transbronchial biopsy of a target lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increased number of bronchi by virtual navigation route compared to supine position
Key secondary outcomes
Change of lung volume using the virtual navigation system in the lateral and supine positions, and in the endpoints of each lobe in the lateral and supine positions.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have a lesion in the peripheral on chest CT and require biopsy for diagnosis or treatment decision, but the bronchus cannot reach the target lesion even with branch reading or VBN
2. 20 years old or more
3. Provision of written informed consent
Key exclusion criteria
1.Patients for whom supine CT allows adequate branch making or virtual bronchoscopic route creation.
2.Patients whose lesion is 1/3 from the pulmonary hilum.
3.Pregnant women or women of childbearing potential
4.Patients whose lateral CT scan is more than 4 weeks after the supine CT scan
5.Patients who have difficulty maintaining the supine position.
Target sample size
20
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
7011192
Address
1711-1 Tamasu Kitaku Okayama City
TEL
08063041024
tacky1024@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
08063041024
Homepage URL
tacky1024@gmail.com
Sponsor or person
Institute
NHO Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO Okayama Medical Center
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
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
| 2024 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the protocol has been approved by the Director, case enrollment will begin until December 2025 (the period of accumulation may be changed depending on the status of case enrollment). The study period, including the follow-up period, will be until the end of December 2026.
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062285
