UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009268
Receipt number R000010883
Scientific Title Usefulness of a continuous suction mouthpiece during endoscopic submucosal dissection
Date of disclosure of the study information 2012/11/06
Last modified on 2012/11/06 21:20:35

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Basic information

Public title

Usefulness of a continuous suction mouthpiece during endoscopic submucosal dissection

Acronym

Usefulness of a continuous suction mouthpiece during ESD

Scientific Title

Usefulness of a continuous suction mouthpiece during endoscopic submucosal dissection

Scientific Title:Acronym

Usefulness of a continuous suction mouthpiece during ESD

Region

Japan


Condition

Condition

Patiens who need endoscopic submucosal dissection (ESD)

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A new continuous suction mouthpiece (CSM) was developed, and its usefulness for endoscopic submucosal dissection (ESD) was evaluated.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Aspiration pneumonia after the endoscopic submucosal dissection (ESD) were evaluated.

Key secondary outcomes

Extent of salivary flow, frequency of saliva suction, and number of choking episodes during endoscopic submucosal dissection (ESD) were evaluated


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

continuous suction mouthpiece

Interventions/Control_2

conventional type mouthpiece

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 and Female

Key inclusion criteria

Patients who need endoscopic submucosal dissection

Key exclusion criteria

Patients were excluded if they had a history of respiratory problems.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Maekita

Organization

School of Medicine, Wakayama Medical University

Division name

Department of Gastroenterology

Zip code


Address

811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan

TEL

073-447-2300

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takao Maekita

Organization

School of Medicine, Wakayama Medical University

Division name

Department of Gastroenterology

Zip code


Address

811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan

TEL

073-447-2300

Homepage URL


Email



Sponsor or person

Institute

School of Medicine, Wakayama Medical University, Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

School of Medicine, Wakayama Medical University, Department of Gastroenterology

Organization

Division

Category of Funding Organization

Local Government

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

和歌山県立医科大学附属病院(和歌山県)


Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 06 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

2012 Year 11 Month 06 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 06 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

2012 Year 11 Month 06 Day

Last modified on

2012 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name