UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020101
Receipt number R000023222
Scientific Title First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy
Date of disclosure of the study information 2015/12/07
Last modified on 2015/12/07 17:03:32

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Basic information

Public title

First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy

Acronym

First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy

Scientific Title

First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy

Scientific Title:Acronym

First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy

Region

Japan


Condition

Condition

Patients with gastrointestinal bleeding or inadequate preparation for endoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety and efficacy of a novel method to secure the visual field using gel during endoscopy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Subjective evaluation of efficacy of this method by the operator after the procedure

Key secondary outcomes

Adverse event related to the method using gel


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

Diagnosis

Type of intervention

Food

Interventions/Control_1

During endoscopy, when it is difficult to secure the visual field by using air insufflation and water immersion, we inject gel through the accessory channel.

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


 Not applicable

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with gastrointestinal bleeding or inadequate preparation for endoscopy

Key exclusion criteria

(A) acute abdomen
(B) severe inflammation
(C) pregnant woman
(D) poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor
(E) patient who is judged to be unsuitable for this clinical trial

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironori Yamamoto

Organization

Jichi Medical University

Division name

Department of Medicine, Division of Gastroenterology

Zip code


Address

3311-1 Yakushiji,Shimomituke,Tochigi,JAPAN 329-0498

TEL

0285-58-7348

Email

ireef@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomonori Yano

Organization

Jichi Medical University

Division name

Department of Medicine, Division of Gastroenterology

Zip code


Address

3311-1 Yakushiji,Shimomituke,Tochigi,JAPAN 329-0498

TEL

0285-58-7348

Homepage URL


Email

tomonori@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nothing

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

自治医科大学附属病院（栃木県）


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://dx.doi.org/10.1016/j.gie.2015.09.048

Number of participants that the trial has enrolled


Results

This method was used in 17 consecutive patients. Of these 17 patients, gel injection was very effective in 10, effective in 5, slightly effective in 1, and not effective in 1. There were no adverse events associated with this method.

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

Main results already published

Date of protocol fixation

2014 Year 02 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 09 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry

2015 Year 10 Month 31 Day

Date trial data considered complete

2015 Year 10 Month 31 Day

Date analysis concluded

2016 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 07 Day

Last modified on

2015 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name