UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Whether the objectives of the examination are achieved or not

Key secondary outcomes

Incidence of adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Given Imaging K.K.

Institute

Department

Personal name

Organization

Given Imaging K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

National Cancer Center Hospital
Jikei University School of Medicine
Hiroshima University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター
東京慈恵会医科大学
広島大学

Date of disclosure of the study information

2012

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

02

Month

10

Day

Last modified on

2014

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008565