UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016556 |
|---|---|
| Receipt number | 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 17:19:57 |
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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
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
irisawa@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019199
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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