UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017074
Receipt number R000019769
Scientific Title Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Date of disclosure of the study information 2015/04/10
Last modified on 2017/09/19 10:05:13

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Basic information

Public title

Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.

Acronym

Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.

Scientific Title

Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.

Scientific Title:Acronym

Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.

Region

Japan


Condition

Condition

Gastric or Esophageal Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of Hook knife with water jet function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The insertion number of injection needle per resected area.

Key secondary outcomes

Procedure duration of ESD per resected area (from injection to the end of dissection)
The number and amount of the injection from mucosa by injection needle per resected area
The number and amount of the injection to submucosal layer by injection needle per resected area
The number and amount of the injection from mucosa by Hook knife with water jet function per resected area
The number and amount of the injection to submucosal layer by Hook knife with water jet function per resected area


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hook Knife

Interventions/Control_2

Hook Knife with Water Jet Function

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

1) Gastric or esophageal cancer which has indication of endoscopic submucosal dissection.
2) Written and signed consent for trial participation must be obtained from the patient.

Key exclusion criteria

1) Prior radiotherapy from mediastinum to upper abdomen.
2) The subject judged as without eligibility for the safety of this study by lead principal investigator or contact doctor.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuneo Oyama

Organization

Saku Central Hospital Advanced Care Center

Division name

Department of Endoscopy

Zip code


Address

3400-28 Nakagomi, Saku, JAPAN

TEL

0267-62-8181

Email

oyama@coral.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Takahashi

Organization

Saku Central Hospital Advanced Care Center

Division name

Department of Endoscopy

Zip code


Address

3400-28 Nakagomi, Saku, JAPAN

TEL

0267-62-8181

Homepage URL


Email

ctroffice@sakuhp.or.jp


Sponsor or person

Institute

Saku Central Hospital Advanced Care Center

Institute

Department

Personal name



Funding Source

Organization

Saku Central Hospital Advanced Care Center

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

佐久総合病院佐久医療センター(長野県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 03 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2015 Year 11 Month 28 Day

Date analysis concluded

2016 Year 09 Month 13 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 08 Day

Last modified on

2017 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019769


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name