UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016392
Receipt number R000019039
Scientific Title Trans-enteral bowel preparation for colonoscopy with unsedated transnasal endoscopy: feasibility and safety in elderly patients with dysphagia
Date of disclosure of the study information 2015/01/30
Last modified on 2020/02/03 12:51:29

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Basic information

Public title

Trans-enteral bowel preparation for colonoscopy with unsedated transnasal endoscopy: feasibility and safety in elderly patients with dysphagia

Acronym

Trans-enteral bowel preparation for colonoscopy with unsedated transnasal endoscopy: in elderly patients

Scientific Title

Trans-enteral bowel preparation for colonoscopy with unsedated transnasal endoscopy: feasibility and safety in elderly patients with dysphagia

Scientific Title:Acronym

Trans-enteral bowel preparation for colonoscopy with unsedated transnasal endoscopy: in elderly patients

Region

Japan


Condition

Condition

Elderly patients with dsyphasia who need colonoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of bowel preparation for colonoscopy with elderly patients with dysphagia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate

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

Maneuver

Interventions/Control_1

Administration of polyethylene glycol with transnasal endoscopy

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All elderly patients hoping this preparation.
Elderly patients with dysphagia

Key exclusion criteria

Patients having difficulty in endoscopic approach

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Mori

Organization

Ichnomiya Nishi Hospital

Division name

Gastroenterology

Zip code

4940001

Address

1 Hira Kaimei Ichinomiya Aichi Japan

TEL

0586-48-0077

Email

a-mori@anzu.or.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Mori

Organization

Ichnomiya Nishi Hospital

Division name

Gastroenterology

Zip code

4940001

Address

1 Hira Kaimei Ichinomiya Aichi Japan

TEL

0586-48-0077

Homepage URL

http://www.anzu.or.jp

Email

a-mori@anzu.or.jp


Sponsor or person

Institute

Ichinomiya Nishi Hospital

Institute

Department

Personal name



Funding Source

Organization

Ichnomiya Nishi 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

Ichinomiya Nishi Hospital

Address

1 Hira Kaimei

Tel

0586480077

Email

a-mori@anzu.or.jp


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 30 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

2015 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 30 Day

Last follow-up date

2015 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 01 Month 30 Day

Last modified on

2020 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019039