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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016556
Receipt No. R000019199
Scientific Title Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Date of disclosure of the study information 2015/02/16
Last modified on 2018/02/19

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Basic information
Public title Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Acronym Investigation of magnetically guided capsule endoscope system for stomach inspection
Scientific Title Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsushi Irisawa
Organization Fukushima Medical University Aizu Medical Center
Division name Department of Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
TEL 0242-75-2100
Email irisawa@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Irisawa
Organization Fukushima Medical University Aizu Medical Center
Division name Department of Gastroenterology
Zip code
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)

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
2015 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2015 Year 02 Month 16 Day
Date of IRB
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

Other
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

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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