UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008600
Receipt number R000009979
Scientific Title Evaluation of efficacy of Double Nasal-Scope Mucosal Cutdown Biopsy using the transnasal endoscope corresponding to the high frequency in gastric submucosal tumor.
Date of disclosure of the study information 2012/08/02
Last modified on 2015/09/11 10:36:42

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Basic information

Public title

Evaluation of efficacy of Double Nasal-Scope Mucosal Cutdown Biopsy using the transnasal endoscope corresponding to the high frequency in gastric submucosal tumor.

Acronym

Evaluation of efficacy of Double Nasal-Scope Mucosal Cutdown Biopsy using the transnasal endoscope corresponding to the high frequency in gastric submucosal tumor.

Scientific Title

Evaluation of efficacy of Double Nasal-Scope Mucosal Cutdown Biopsy using the transnasal endoscope corresponding to the high frequency in gastric submucosal tumor.

Scientific Title:Acronym

Evaluation of efficacy of Double Nasal-Scope Mucosal Cutdown Biopsy using the transnasal endoscope corresponding to the high frequency in gastric submucosal tumor.

Region

Japan


Condition

Condition

Gastric submucosal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy and safety of Double Nasal-Scope Mucosal Cutdown Biopsy in small gastric submucosal tumor of one to two cm using to the new device "Nanoshooter".

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of confirmed diagnosis by a biopsy.

Key secondary 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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

EG-580NW
Nanoshooter

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

18 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1)The patient's age is between 18 and 89 years old.
2)The patient who has diagnosis of gastric submucosal tumor.
3)Hospitalization.
4)Informed Consent.
5)The patient that contraception is possible during the study.

Key exclusion criteria

1)At their own request of resignation or withdrawal of informed consent.
2)It was found that patients do not satisfy the criteria after entry.
3)Patients who are judged to be difficult treatment for worsening of the underlying disease.
4)Patients with severe renal failure, liver failure, circulatory failure.
5)Patients who are pregnant, suspected to be pregnant or breastfeeding.
6)Patients with drug allergy and/or history of severe side effects due to analgesic and/or sedatives.
7)Patients who are judged to be difficult treatment for complications.
8)Stop of this study.
9)Patients who are considered to be inapproriate by the investigators.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakatsu Nakamura

Organization

Kanazawa Medical University

Division name

Department of Gastroenterology

Zip code


Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masakatsu Nakamura

Organization

Kanazawa Medical University

Division name

Department of Gastroenterology

Zip code


Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

TEL


Homepage URL


Email



Sponsor or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University

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

2012 Year 08 Month 02 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

2012 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 02 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 08 Month 02 Day

Last modified on

2015 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name