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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029980
Receipt No. R000033982
Scientific Title Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia.
Date of disclosure of the study information 2017/11/30
Last modified on 2017/11/15

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Basic information
Public title Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia.
Acronym BTUS study
Scientific Title Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia.
Scientific Title:Acronym BTUS study
Region
Japan

Condition
Condition Spinal and spinal cord surgery in lumber level
Classification by specialty
Orthopedics Urology Anesthesiology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of new device for bulbocavernosus reflex monitoring using transurethral stimulation under general anaesthesia to record successfully with high reliability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate for recording control waveform of BCR monitoring
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of stimulation catheter into urethra
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
100 years-old >=
Gender Male
Key inclusion criteria Spinal and spinal cord surgery in lumbar level
Key exclusion criteria Urethral disease
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeaki Shinjo
Organization Nara Medical University
Division name Anaesthesiolosy
Zip code
Address 840, Sijo, Kasihara, Nara, Japan
TEL 0744-22-3051
Email tshinjo@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Shinjo
Organization Nara Medical University
Division name Anaesthesiolosy
Zip code
Address 840, Sijo, Kasihara, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email tshinjo@hotmail.co.jp

Sponsor
Institute Depertment of Anaesthesiolosy, Nara Medical University
Institute
Department

Funding Source
Organization Depertment of Anaesthesiolosy, Nara Medical University
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
Email

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 11 Month 30 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 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 11 Month 15 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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