UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Title of the study (Brief title)	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	Haruhjiko Ogata, MD
Organization	Keio University
Division name	Center for diagnostic therapeutic endoscopy
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	+81-3-3353-1211
Email	hogata@keio.jp

Public contact
Name of contact person	Naoki Hosoe, MD
Organization	Keio University
Division name	Center for diagnostic therapeutic endoscopy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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