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

* 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

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 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


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

Value
https://center6.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