UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055249 |
|---|---|
| Receipt number | R000063134 |
| Scientific Title | Investigation of the influence of body position on bronchoscopy |
| Date of disclosure of the study information | 2024/08/15 |
| Last modified on | 2024/08/15 13:02:22 |
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Basic information
Public title
Investigation of the influence of body position on bronchoscopy
Acronym
Investigation of the influence of body position on bronchoscopy
Scientific Title
Investigation of the influence of body position on bronchoscopy
Scientific Title:Acronym
Investigation of the influence of body position on bronchoscopy
Region
| Japan |
Condition
Condition
Pulmonary Peripheral Lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is a single-center prospective observational study to determine how to obtain precise bronchial information prior to bronchoscopy by performing chest CT imaging in both the supine and lateral positions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Information volume of bronchial tree generated by analyzing CT images with virtual bronchoscope navigation.
(2) Bronchial diameter measured by analyzing CT images with virtual bronchoscope navigation.
(3) Lung lobe volume measured by analyzing CT images with virtual bronchoscope navigation.
(4) Comparison of the position reached by the bronchoscope in the supine and side-lying positions and the bronchial diameter measured by analyzing the CT images in (2).
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 undergoing bronchoscopy at Osaka University Hospital
The subject of bronchoscopy must have a solitary lesion in the peripheral lung field.
Those who are 20 years of age or older at the time of consent.
Those who have given written consent to participate in the study.
Key exclusion criteria
Patients who cannot undergo bronchoscopy
Other patients who are deemed unsuitable by the principal investigator or principal study authorization holder
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Hospital
Division name
Respiratory Medicine
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
kotaromiyake@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Hospital
Division name
Respiratory Medicine
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
Homepage URL
kotaromiyake@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
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
IRB of Osaka University
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
Tel
0668795111
rinri@hp-crc.med.osaka-u.ac.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
| 2024 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling
Management information
Registered date
| 2024 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063134
