UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030539 |
|---|---|
| Receipt number | 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 | 2022/01/09 22:26:13 |
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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
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
sososawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034862
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