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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012846
Receipt No. 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

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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
Email 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
Email mmatsumo@ncc.go.jp

Sponsor
Institute Endoscopy Division, National Cancer Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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