UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012846 |
|---|---|
| Receipt number | R000015007 |
| Scientific Title | Feasibility of capsule endoscopy for the screening of small intestinal lesions in patients with familial adenomatous polyposis |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2016/07/14 16:38:56 |
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Basic information
Public title
Feasibility of capsule endoscopy for the screening of small intestinal lesions in patients with familial adenomatous polyposis
Acronym
Feasibility of capsule endoscopy in patients with familial adenomatous polyposis
Scientific Title
Feasibility of capsule endoscopy for the screening of small intestinal lesions in patients with familial adenomatous polyposis
Scientific Title:Acronym
Feasibility of capsule endoscopy in patients with familial adenomatous polyposis
Region
| Japan |
Condition
Condition
Familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the current study is to evaluate a feasibility of capsule endoscopy in familial adenomatous polyposis patients who had previously undergone colorectal surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of capsule endoscopy
Key secondary outcomes
Evaluation of small intestinal lesions in familial adenomatous polyposis patients who had a history of colorectal surgery.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Familial adenomatous polyposis patients who were admitted to our hospital. All patients had undergone colorectal surgery.
Key exclusion criteria
Severe swallowing disorders
Pregnancy
Implanted cardiac pacemaker
Planned MR examination within the next 2week
Clinical suspicion of an intestinal obstruction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy
Zip code
Address
5-1-1, Tukiji Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minori Matsumoto |
Organization
National Cancer Center Hospital
Division name
Endoscopy
Zip code
Address
5-1-1, Tukiji Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
mmatsumo@ncc.go.jp
Sponsor or person
Institute
Endoscopy Division, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 16 | Day |
Other
Other related information
Capsule endoscopy was offered to 70 consecutive patients who were admitted to our hospital. All patients gave their written informed consent.
Management information
Registered date
| 2014 | Year | 01 | Month | 14 | Day |
Last modified on
| 2016 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015007
