UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005137
Receipt No. R000006093
Scientific Title Examination of clinical utility of XX-45(double-balloon enteroscope)
Date of disclosure of the study information 2011/02/25
Last modified on 2011/02/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination of clinical utility of XX-45(double-balloon enteroscope)
Acronym Examination of clinical utility of double-balloon enteroscope
Scientific Title Examination of clinical utility of XX-45(double-balloon enteroscope)
Scientific Title:Acronym Examination of clinical utility of double-balloon enteroscope
Region
Japan

Condition
Condition Patients for whom endoscopic observation of the depth of the small bowel is considered necessary,corresponding to any of the following:
- Patient with suspected Obscure
Gastrointestinal Bleeding(OGIB)
- Patient with suspected overt small
intestinal bleeding
- Patient with suspected small
intestinal diseases below;
Crohn's dsease,erosion,nulcer,
malignant tumour,benign tumour,
polyp,inflammatiom,diverticulum,
angiodysplasia,stenosis,
malabsorption syndrome,protein-
losing gastroenteropathy
- Patient requiring the removal of
foreign bodies in the small bowel
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the safety and efficacy of XX-45 in the patients who require endoscopic observation of the small bowel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes - Whether or not the objectives of the
examination were achieved
- Incidence of adverse events
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of XX-45 via an oral and/or anal route
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
13 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Age::13 to 79 years old
Gender::Not specified
Inpatient/outpatient:Not specified
Key exclusion criteria 1)Patients with acute abdomen
2)Patients with severe acute inflammation
3)Patients with anaphylaxis to natural rubber
4)Patients in a very bad general condition
5)Patients with suspected intestinal perforation
6)Patients having severe blood clotting defect
7)Patients with severe hepatic function disorder
8)Patients with severe respiratory diseases or circulatory diseases
9)Gravida and possibly pregnant patients
10)Patients who have participated in other clinical trials within 3 months prior to the start of this trial.
11)Patients who do not have the capacity or intention to cooperate with the trial procedures.
12)Patients who have experienced any adverse reactions through the enteroscopy.
13)Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.
14)Sick or injured persons in life-threatening conditions and from whom it seems difficult to obtain written informed consent for their participation in the trial.
15)Patients with whom insertion of the endoscope has to be conducted via the stoma.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Yamamoto,M.D,Ph.D
Organization Jichi Medical University Hospital
Division name Endoscopy Center
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL 0285-58-7539
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Kikuchi
Organization FUJIFILM Corporation
Division name Endoscopy Systems Div.
Zip code
Address 26-30,Nishiazabu 2-Chome Minato-ku,Tokyo 106-8620,Japan
TEL 03-6418-9141
Homepage URL
Email katsuya_b_kikuchi@fujifilm.co.jp

Sponsor
Institute FUJIFILM Corporation
Institute
Department

Funding Source
Organization FUJIFILM Corporation
Organization
Division
Category of Funding Organization Profit organization
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 財団法人厚生会 仙台厚生病院(宮城県)
自治医科大学附属病院(栃木県)
日本医科大学付属病院(東京都)
昭和大学藤が丘病院(神奈川県)
名古屋大学医学部附属病院(愛知県)
広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 25 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
2008 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 08 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 25 Day
Last modified on
2011 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.