UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030539
Receipt No. R000034862
Scientific Title Clinical usefulness of second generation colon capsule endoscopy (CCE-2) in patients with ulcerative colitis
Date of disclosure of the study information 2017/12/24
Last modified on 2018/12/25

* 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 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
Middle name
Last name Satoshi Osawa
Organization Hamamatsu University School of Medicine
Division name Department of Endoscopic and Photodynamic Medicine
Zip code
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
Middle name
Last name Satoshi Osawa
Organization Hamamatsu University School of Medicine
Division name Department of Endoscopic and Photodynamic Medicine
Zip code
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
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 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2020 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
2018 Year 12 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.