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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017796
Receipt No. R000020617
Scientific Title Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Date of disclosure of the study information 2015/06/03
Last modified on 2018/10/12

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Basic information
Public title Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Acronym Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Scientific Title Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Scientific Title:Acronym Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim1: To develope a scoring system to assess the endoscopic severity of ulcerative colitis (UC) using second generation colon capsule endoscope (CCE-2).
Aim2: To valideate the colon capsule scoring system for UC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Phase1: Correlation between developed colon capsule score for UC and value of fecal calprotectin.
Phase2: Kappa value for developed colon capsule score for UC.
Key secondary outcomes Correlation between developed colon capsule score for UC and patinets outcome. Correlation between developed colon capsule score for UC and Lichtiger score, number of white blood cell, CRP level.

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Colon examination by using colon capsule 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed UC patients
Key exclusion criteria 1) Ppatients with dysphagia.
2) Pregnant female.
3) Patient with pacemaker or other medical electronic equipment.
4) Patients who have history of the ileus or stricture or fistula of the intestine.
5) Patients who have history of radiation therapy.
6) Diagnosed or suspected Crohn's disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhjiko Ogata, MD
Organization Keio University
Division name Center for diagnostic therapeutic endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Email hogata@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, MD
Organization Keio University
Division name Center for diagnostic therapeutic endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Homepage URL
Email hosenao@gmail.com

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Medtronic Co.
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 慶應義塾大学 消化器内科
北里大学北里研究所病院 炎症性腸疾患先進治療センター
東京医科歯科大学 消化器内科
東邦大学医療センター佐倉病院 消化器内科
大船中央病院 消化器IBDセンター、光学診療部

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 03 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 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Phase1: The UC patients will be examined by CCE-2 and CS. And a scoring system to assess the endoscopic severity of ulcerative colitis (UC) using second generation colon capsule endoscope develope (CCE-2) is developed.
Phase2: The developed colon capsule score for UC will be validated.

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020617

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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