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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name