UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022320 |
|---|---|
| Receipt number | R000025713 |
| Scientific Title | Clinical study on the efficacy of trans-esophageal motor evoked potentials |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/05/18 12:15:54 |
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Basic information
Public title
Clinical study on the efficacy of trans-esophageal motor evoked potentials
Acronym
Clinical study on the efficacy of trans-esophageal motor evoked potentials
Scientific Title
Clinical study on the efficacy of trans-esophageal motor evoked potentials
Scientific Title:Acronym
Clinical study on the efficacy of trans-esophageal motor evoked potentials
Region
| Japan |
Condition
Condition
aortic aneurysm, aortic dissection, traumatic aortic injury
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of trans-esophageal motor evoked potentials to monitor spinal cord function during aortic surgery, in comparison to trans-cranial motor evoked potentials that has been clinically used
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amplitudes and their stability
Key secondary outcomes
quickness in response to spinal cord ischemia
correlation between amplitude change and operative procedures/neurological 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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Trans-esophageal motor evoked potentials are elicited by electrical spinal cord stimulation through a special esophageal surface electrodes (not approved, experimental device) that is introduced nasally or orally. Stimulation was repeated every 3 to 5 minutes, using one electrode for one operation, for several hours during surgery.
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 aortic surgery that carries the risk of ischemic spinal cord injury, in whom trans-cranial motor evoked potentials are to be monitored as a routine clinical practice (surgery mainly on the descending and thoracoabdominal aorta)
Key exclusion criteria
patients with esophageal disease
physician's decision
unconsenting patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norihiko |
| Middle name | |
| Last name | Shiiya |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
+81534352276
shiyanor@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Shiiya |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
+81534352276
Homepage URL
shiyanor@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
Institutional review board, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel
0534352680/+81534352680
rinri@hama-med.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
| 2016 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025713
