UMIN-CTR Clinical Trial

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

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015109
Receipt No. R000017571
Scientific Title Examination of the small intestine lesion using a capsule small intestine endoscope and the double balloon small intestine endoscopy for Hereditary polyposis syndromes
Date of disclosure of the study information 2014/09/10
Last modified on 2019/03/15

* 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 Examination of the small intestine lesion using a capsule small intestine endoscope and the double balloon small intestine endoscopy for Hereditary polyposis syndromes
Acronym Examination of the small intestine lesion using a capsule small intestine endoscope and the double balloon small intestine endoscopy for Hereditary polyposis syndromes
Scientific Title Examination of the small intestine lesion using a capsule small intestine endoscope and the double balloon small intestine endoscopy for Hereditary polyposis syndromes
Scientific Title:Acronym Examination of the small intestine lesion using a capsule small intestine endoscope and the double balloon small intestine endoscopy for Hereditary polyposis syndromes
Region
Japan

Condition
Condition Familial adenomatous polyposis
Peutz-Jeghers syndrome
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 I perform the small intestine observation with a capsule endoscope and the double balloon small intestine endoscope for FAP and PJS patients and examine the frequency of the small intestine polyps.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscope views, blood laboratory findings, clinical manifestations
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 I inspect having variation or not of the APC gene and LKB-1 gene
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)The patient who had a diagnosis of Familial adenomatous polyposis or Peutz-
Jeghers syndrome 15 years or older
2)The patient who does not have a small intestinal stenosis causing the stoppage of the small intestine capsule endoscope
Key exclusion criteria 1)Patient having a small intestinal stenosis causing the stoppage of the small intestine capsule endoscope endoscope
2)Patient having a disease causing a drop of the gastrointestinal exercise including diabetes
3)Patient who buries a medical appliance
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayama
Organization Tokushima university hospital
Division name gastroenterological medicine
Zip code
Address 2-50-1 Kuramoto,Tokushima Japan
TEL 088-633-7124
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tanaka
Organization Tokushima university hospital
Division name gastroenterological medicine
Zip code
Address 2-50-1 Kuramoto,Tokushima Japan
TEL 088-633-7124
Homepage URL
Email tanaka.kumiko.1@tokushima-u.ac.jp

Sponsor
Institute Tokushima university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017571


Contact us.