UMIN-CTR Clinical Trial

Basic information
Public title	Clinical usefulness of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis
Acronym	Clinical usefulness of colon capsule endoscopy in patients with ulcerative colitis
Scientific Title	Clinical usefulness of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis
Scientific Title:Acronym	Clinical usefulness of colon capsule endoscopy in patients with ulcerative colitis
Region	Japan

Condition
Condition	Patient with ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the clinical usefulness, safety, and compliance of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis. To examine whether the severity of mucosal inflammation by CCE-2 is associated with thereafter bad outcome such as clinical relapse.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The rate of total colon observation within its battery life, and transit time 2. Severity of mucosal inflammation in clinical remission assessed by CCE using Mayo endoscopic subscore (Mayo ES) and Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Key secondary outcomes	1. Cleansing level with a 4-point grading scale (poor, fair, good, and excellent) 2. Adverse events 3. Relapse-free survival, Exacerbation-free survival, surgery-free survival 4. Acceptability of CCE assessed by questionnaire survey.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with known ulcerative colitis Category A: outpatient, in clinical remission defined as the Rachmilewitz index of 0-4 points Category B: active inpatient 2. Written informed consent
Key exclusion criteria	1. Patients with dysphagia 2. Pregnant or possible pregnant women 3. Patients with a pacemaker or other implanted electromedical device 4. Patients with present or past history of small and large bowel obstruction 5. Patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition) 6. Patients with an allergy to polyethylene glycol, magnesium citrate, sennoside, metoclopramide or mosapride citrate 7. Patients who will undergo MRI 2 weeks after CCE 8. Patients inappropriate for this study by other reasons judged by investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Osawa
Organization	Hamamatsu University School of Medicine
Division name	Department of Endoscopic and Photodynamic Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
TEL	+81-53-435-2261
Email	sososawa@hama-med.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Osawa
Organization	Hamamatsu University School of Medicine
Division name	Department of Endoscopic and Photodynamic Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
TEL	+81-53-435-2261
Homepage URL
Email	sososawa@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine
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	The Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
Tel	+81-53-435-2850
Email	rinri@hama-med.ac.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	浜松医科大学医学部附属病院（静岡県）/Hamamatsu University Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially 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	Main results already published
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2016 Year 11 Month 04 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	consecutive cases, prospective study Actual study start date: October 2015 now registering Partially publishied; World J Clin Cases. 2018 Dec 6;6(15):952-960. doi:10.12998/wjcc.v6.i15.952. PubMed PMID:30568951; PubMed Central PMCID:PMC6288494.

Management information
Registered date	2017 Year 12 Month 24 Day
Last modified on	2022 Year 01 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034862