UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016120
Receipt number R000018286
Scientific Title Efficacy of stylet for insertion efficacy for ProSeal insertion
Date of disclosure of the study information 2015/01/05
Last modified on 2015/04/21 22:31:44

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Basic information

Public title

Efficacy of stylet for insertion efficacy for ProSeal insertion

Acronym

Stylet efficacy for ProSeal insertion

Scientific Title

Efficacy of stylet for insertion efficacy for ProSeal insertion

Scientific Title:Acronym

Stylet efficacy for ProSeal insertion

Region

Japan


Condition

Condition

Patients who undergo general anesthesia

Classification by specialty

Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the role of stylet for ProSeal insertion

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

insertion time, insertion number, sealing pressure, pharyngel pain

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Stylet for ProSeal insertion

Interventions/Control_2

Without stylet for ProSeal insertion

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who undergo general anesthesia

Key exclusion criteria

Emergency Operation

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minami Toshiaki

Organization

Department of Anesthesiolog, Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuk city

TEL

0726-84-6361

Email

ane022@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Komasawa Nobuyasu

Organization

Osaka Medical College

Division name

Department of Anesthesiology

Zip code


Address

2-7Daigaku-machi, Takatsuki city

TEL

0726-84-6361

Homepage URL


Email

koma21century@yahoo.co.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, OMC

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

2015 Year 01 Month 05 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

ProSeal insertion efficacy was improved by 90degree bent

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

2015 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 13 Day

Last follow-up date

2015 Year 04 Month 21 Day

Date of closure to data entry

2015 Year 04 Month 22 Day

Date trial data considered complete

2015 Year 04 Month 29 Day

Date analysis concluded

2015 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 05 Day

Last modified on

2015 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018286


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name