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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007258
Receipt No. R000008565
Scientific Title Study of the clinical usefulness of the PC2-101 Colon Capsule Endoscopy in the detection of lesion of the colon
Date of disclosure of the study information 2012/02/10
Last modified on 2014/01/28

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Basic information
Public title Study of the clinical usefulness of the PC2-101 Colon Capsule Endoscopy in the detection of lesion of the colon
Acronym Study of the clinical usefulness of Colon Capsule Endoscopy
Scientific Title Study of the clinical usefulness of the PC2-101 Colon Capsule Endoscopy in the detection of lesion of the colon
Scientific Title:Acronym Study of the clinical usefulness of Colon Capsule Endoscopy
Region
Japan

Condition
Condition Subjects who have a history of receiving a colon endoscope test within the last 3 months and who are known to have a lesion for which endoscopic or surgical treatment is necessary according to a colon endoscope test result findings report in which all observed lesions were noted
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the clinical study is to evaluate the sensitivity of the Colon Capsule Endoscopy with Colon Endoscopy in subjects who have lesions that were determined by colon endoscopy tests as required endoscopic or surgical treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Whether the objectives of the examination are achieved or not
Key secondary outcomes Incidence of adverse events

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Oral ingestion of PC2-101
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Over 18 years old-individuals who have known lesions detected by Colonoscopy within the last 3 months before the screening day.
(2) Individuals who can receive Colon Capsule Endoscopy within 1 month after the screening day.
(3) Individuals with written informed consent
Key exclusion criteria Individuals
1. who have dysphasia
2. who have known or suspected occlusion, stenosis, or a fistula of the digestive tract in abdominal x-ray test, abdominal ultrasound test, in their medical/ surgical history, in their clinical findings, or the like (this excludes cases where determination was not possible using the methods indicated above, but possible to confirm the absence of stenosis in small intestine double contrast testination including simple method)
3. who received radiological treatment of the pelvic viscera and with suspected stenosis due to radiological enterocolitis
4. who have a history of surgical procedure within the abdominal cavity (e.g. colostomy procedure or bypass procedure) and for whom the absence of any problem in carrying out the present investigation cannot be confirmed with appropriate test including small bowel test
5. who have embedded electrical endoscopic or surgical device, e.g. a cardiac pacemaker
6. with scheduled MRI test
7. with known gastrointestinal motility function disorder that makes it difficult to carry out this study
8. with known delayed gastric emptying that makes it difficult to carry out this study
9. with history of long-term administration of NSAIDs and with suspected of having a stenosis due to bowel disease caused by the NSAIDs
10. with a serious heart condition
11. with any type of allergy or warning/contraindication against the drugs to be used in this study
12. who are/may be pregnant or breastfeeding,
13. whose clinical condition may not enable to carry out required items from the study protocol or that may limit participation in the study
14. with fatal conditions
15. with lesions for which surgical treatment is necessary, and which may become advanced rapidly.
16. with scheduled participation in other clinical studies during the clinical study duration.
17. who clinical study principal investigator, or subinvestigator has determined are not suitable for participation in this study
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Saito MD, PhD
Organization National Cancer Center Hospital
Division name Gastrointestinal Endoscopy Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email ytsaito@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Kamei
Organization Given Imaging K.K.
Division name Regulatory & Clinical Affairs, QA/QC Dpt.
Zip code
Address 3-3 Kojimachi, Chiyoda-ku, Tokyo
TEL 03-5214-0585
Homepage URL
Email tomoya.kamei@givenimaging.com

Sponsor
Institute Given Imaging K.K.
Institute
Department

Funding Source
Organization Given Imaging K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital
Jikei University School of Medicine
Hiroshima University
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
東京慈恵会医科大学
広島大学

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2011 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 10 Day
Last modified on
2014 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008565

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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