UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027572 |
|---|---|
| Receipt number | R000031610 |
| Scientific Title | A clinical use of the administration of local anethetic drug by a novel bronchoscopic catheter spray device |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/31 17:13:08 |
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Basic information
Public title
A clinical use of the administration of local anethetic drug by a novel bronchoscopic catheter spray device
Acronym
A clinical use of the administration of local anethetic drug by a novel bronchoscopic catheter spray device
Scientific Title
A clinical use of the administration of local anethetic drug by a novel bronchoscopic catheter spray device
Scientific Title:Acronym
A clinical use of the administration of local anethetic drug by a novel bronchoscopic catheter spray device
Region
| Japan |
Condition
Condition
Diseases needed to undergo bronchoscopy
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usability, safety and efficacy of bronchoscopic catheter spray device to administrate the local anesthetic drug during bronchoscopic examination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usability, safety and efficacy of the bronchoscopic catheter spray device
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Only once during just bronchoscopic examination
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
| 13 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients whom are torelate to perform bronchoscopic examination
Key exclusion criteria
Patients with lidocaine allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Toba |
Organization
Tokushima University hospital
Division name
Chest surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7143
ht1109@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Toba |
Organization
Tokushima University Hospital
Division name
Chest surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7143
Homepage URL
ht1109@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima Univeristy Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima university Hospital
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
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031610
