UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Title of the study (Brief title)	Investigation of magnetically guided capsule endoscope system for stomach inspection
Region	Japan

Condition
Condition	Conditions are as follows. 1. Tumor (adenoma, early cancer, advanced cancer) 2. Ulcer (including ulcer scar) 3. Fundic gland polyp 4. Hyperplastic polyp 5. Post endoscopic therapy for stomach tumor 6. Portal hypertensive gastropathy 7. Submucosal tumor 8. Varices 9. Or people with no symptoms who desire capsule endoscopic inspection.
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To preliminarily investigate efficacy and safety for magnetically guided capsule endoscope system to people with stomach diseases or no symptoms who desire capsule endoscopic inspection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity of capsule endoscopy to major diseases of stomach (adenoma, early cancer, advanced cancer)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Performing conventional endoscopy and capsule endoscopy to identical subject.
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	1) Patient who have following stomach diseases. Major stomach diseases: 1. Tumor [adenoma, early cancer, advanced cancer] Other stomach diseases: 2. Ulcer (including ulcer scar) 3. Fundic gland polyp 4. Hyperplastic polyp 5. Post endoscopic therapy for stomach tumor 6. Portal hypertensive gastropathy 7. Submucosal tumor 8. Varices Or subjects with no symptoms who desire capsule endoscopic inspection. 2) Patient who agree to participate in this trial by written informed consent. 3) Subjects aged over 20 years old. In addition, subjects with no symptoms who desire capsule endoscopic inspection must be more than 40 years old. 4) Subjects weighing less than 135kg.
Key exclusion criteria	1)Subjects diagnosed or suspected as stricture, adhesion, diverticulum, ileus, or fistula of the intestine. 2)Subjects with history of ileus or stricture. 3)Subjects diagnosed as Crohn disease 4)Subjects with gastrointestinal stasis. 5)Pregnant females 6)Subjects being unable to undergo surgery 7)Subjects being unable to intake capsule (11mm (Outer diameter)by13mm (length)) 8)Subjects with deglutition disorder, or Zenker diverticulum. 9)Subjects with Zenker diverticulum. 10)Subjects who undergo gastro- intestinal bypass surgery. 11)Subjects with intestinal stent and others which lead to be obstruction to passage of capsule. 12)Subjects with severe esophageal hiatal hernia. 13)Subjects with life-threatening illness. 14)Subjects with severe cardiac arrest, or respiration failure. 15)Subjects undergoing several surgeries or radiation therapies, except for subject judged as appropriate candidate for the trial by the investigators. 16)Subjects participating in other trials 17)Subjects being unable to observe instructions concerning this trial. 18)Subjects with implant described as below. 1. Metallic artificial cardiac valve 2. Artificial ear, or auditory ossicle. 3. Nerve or bone growth stimulator. 4. Perfusion pump. 5. Magnetic stent. 6. Brain aneurysm clip 7. ventricular shunt tube 8. Magnetic wire of eyelids 9. Magnetic artificial eye 10. Cardiac pacemaker 11. Defibrillator. 12. Other implanted electronic device. 19)Subjects with medical products containing metal component abdominally or in low back. 20)Subjects judged as inappropriate candidates for the trial by the investigators.
Target sample size	60

Research contact person
Name of lead principal investigator	Atsushi Irisawa
Organization	Fukushima Medical University Aizu Medical Center
Division name	Department of Gastroenterology
Address	21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
TEL	0242-75-2100
Email	irisawa@fmu.ac.jp

Public contact
Name of contact person	Atsushi Irisawa
Organization	Fukushima Medical University Aizu Medical Center
Division name	Department of Gastroenterology
Address	21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
TEL	0242-75-2100
Homepage URL
Email	irisawa@fmu.ac.jp

Sponsor
Institute	Department of Gastroenterology, Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization	Ministry of Health, Labor, and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	OLYMPUS MEDICAL SYSTEMS CORP.(only device)
Name of secondary funｄer(s)

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	2015 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
Anticipated trial start date	2015 Year 02 Month 16 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019199