UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010795 |
|---|---|
| Receipt number | R000012607 |
| Scientific Title | Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2018/06/20 23:18:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions
Acronym
Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions
Scientific Title
Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions
Scientific Title:Acronym
Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions
Region
| Japan |
Condition
Condition
Benign or malignant pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the navigation system Directpath in bronchoscopy for pulmonary peripheral lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic yield
Key secondary outcomes
Directpath
The bronchial generation order allowing automatic virtual image production
The bronchial generation order for which manual registration is added
Bronchoscope
Consistency with virtual images
The bronchial generation order allowing insertion and the outer diameter of the bronchus on virtual images
The distance from the bronchoscope insertion site to the lesion and the number of bronchial divisions
The bronchial generation order allowing observation
The bronchial generation order allowing observation
Diagnostic yield
Diagnostic yields according to the method and bronchoscope used
Diagnostic yield according to the lesion size
Diagnostic yields according to the distance between the lesion and hilum
Diagnosis yields according to the lesion visualization rate using ultrasound, whether the lesion is visualized, and the positional relationship between the ultrasound probe and lesion Visibility on EBUS.
Diagnostic yield according to location of probe in relation to target lesion
Examination time
Safety, Complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Virtual images toward pulmonary peripheral lesions are produced using Directpath.
Transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) is performed using a 2.8-mm ultrathin bronchoscope (BF-XP260F; channel inner diameter, 1.2 mm; Olympus). Subsequently, endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) /transbronchial needle aspiration (TBNA) with VBN is performed using a 4.0-mm bronchoscope (BF-P260F, inner diameter of the operation channel, 2.0 mm; Olympus).
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. On chest CT images, an abnormal shadow is present in the peripheral area of the lung field, and bronchoscopy is necessary to make a diagnosis or determine treatment principles
2. 20 years of age or older
3. Consent in writing to participate in this study has been obtained from patients themselves
Key exclusion criteria
1. Case with serious concomitant medical illness
2. Central pulmonary lesions
3. Diffuse pulmonary lesions
4. Re-examination due to prior failure in this trial
5. Case with pure ground glass opacity
6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL)
7. Bleeding tendency
8. Pregnant woman
9. Other clinical difficulties in this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Asano |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Pulmonary Medicine and Bronchoscopy
Zip code
Address
4-6-1, Noishiki, Gifu, Japan
TEL
058-246-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akifumi Tsuzuku |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Pulmonary Medicine and Bronchoscopy
Zip code
Address
4-6-1, Noishiki, Gifu, Japan
TEL
058-246-1111
Homepage URL
a.tsuzuku@gmail.com
Sponsor or person
Institute
Gifu Prefectural General 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
Address
Tel
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
岐阜県総合医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012607
