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Prospective study for comparison of detetion rate for AOV between dual capsule endoscopy and single capsuel endoscopy

Status Approved

First Submitted Date

2017/07/25
Registered Date

2017/11/17
Last Updated Date

2017/11/01

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002541
Unique Protocol ID	ED16199
Public/Brief Title	Study for diagnostic accuracy of dual capsule endoscopy
Scientific Title	Prospective study for comparison of detetion rate for AOV between dual capsule endoscopy and single capsuel endoscopy
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	ED16199
Approval Date	2016-09-12
Institutional Review Board Name	Korea University Anam Hospital Institutional review board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seung Han Kim
Title	M.D., Ph.D.
Telephone	+82-2-920-6555
Affiliation	Korea University Anam Hospital
Address	Anam-dong 5 ga, Seongbuk-gu, Seoul 02841, Republic of Korea.
Contact Person for Public Queries
Name	Seung Han Kim
Title	M.D., Ph.D.
Telephone	+82-2-920-6555
Affiliation	Korea University Anam Hospital
Address	Anam-dong 5 ga, Seongbuk-gu, Seoul 02841, Republic of Korea.
Contact Person for Updating Information
Name	Seung Han Kim
Title	M.D., Ph.D.
Telephone	+82-2-920-6555
Affiliation	Korea University Anam Hospital
Address	Anam-dong 5 ga, Seongbuk-gu, Seoul 02841, Republic of Korea.

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-07-18 Actual
Target Number of Participant	50
Primary Completion Date
Study Completion Date
Name of Study	Korea University
Recruitment Status	Recruiting
Date of First Enrollment	2017-07-18 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Trade, Industry & Energy
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Capsule endoscopy (CE) is a noninvasive option for investigating the small bowel disorder. However, several studies have reported that the visualization of the small intestine with CE is suboptimal. In the present study, we aimed to evaluate the diagnostic ability of dual CE examination.

Study Summary Information

Lay Summary

Capsule endoscopy (CE) is a noninvasive option for investigating the small bowel disorder. However, several studies have reported that the visualization of the small intestine with CE is suboptimal. In the present study, we aimed to evaluate the diagnostic ability of dual CE examination.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Diagnosis
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Comparative Analysis of Single and Double Doses of Capsule Endoscopy
Number of Arms	2
Arm 1	Arm Label Comparative Analysis of Double Doses of Capsule Endoscopy
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Two capsule endoscopes were administered simultaneously to determine the lesion detection rate
Arm 2	Arm Label Comparative Analysis of single Dose of Capsule Endoscopy
	Target Number of Participant 25
	Arm Type Active comparator
	Arm Description one capsule endoscope were administered simultaneously to determine the lesion detection rate

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R10.49)Unspecified abdominal pain
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~80Year
	Description OGIB, chronic diarrhea, and chronic abdominal pain
Exclusion Criteria	small bowel stenosis, swallowing difficulties, severe advanced respiratory disease, or cardiovascular or neuropsychiatric disease. Pregnant patients and those with implantable electronic devices were also excluded.
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	detection rate of small bowel lesion
Timepoint	after 24hours
Secondary Outcome(s) 1
Outcome	adverse events
Timepoint	after 24hours

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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