UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029793
Receipt number R000033952
Scientific Title Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Date of disclosure of the study information 2017/11/01
Last modified on 2018/03/12 10:51:42

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Basic information

Public title

Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection

Acronym

Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection

Scientific Title

Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection

Scientific Title:Acronym

Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection

Region

Japan


Condition

Condition

gastric tumor(early gastric cancer, gastric adenoma), colorectal tumor(early colorectal cancer, colorectal adenoma)

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visibility(every 15 minutes and the end of procedure)

Key secondary outcomes

procedure time, number of withdrawal of endoscopy during procedure and adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ESD using endoscope coated with liquid ceramic

Interventions/Control_2

ESD using conventional endoscope

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients who undergo endoscopic submucosal dissecion.
2.Patients who were eligible to this study criteria with written informed consent signed and dated.

Key exclusion criteria

Cases with severe complications are excluded.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hattori Masashi

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code


Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Email

m.hattori@yamashita.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshikawa Masakatsu

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code


Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Homepage URL


Email

m.yoshikawa@yamashita.or.jp


Sponsor or person

Institute

Medical corporation Yamashita Hospital

Institute

Department

Personal name



Funding Source

Organization

Medical corporation Yamashita Hospital

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 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

Open public recruiting

Date of protocol fixation

2017 Year 10 Month 02 Day

Date of IRB


Anticipated trial start date

2017 Year 11 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 01 Day

Last modified on

2018 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033952


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name