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 |
Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Investigation of magnetically guided capsule endoscope system for stomach inspection
Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection
Investigation of magnetically guided capsule endoscope system for stomach inspection
Japan |
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.
Gastroenterology |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Sensitivity of capsule endoscopy to major diseases of stomach (adenoma, early cancer, advanced cancer)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Diagnosis
Device,equipment |
Performing conventional endoscopy and capsule endoscopy to identical subject.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
60
1st name | |
Middle name | |
Last name | Atsushi Irisawa |
Fukushima Medical University Aizu Medical Center
Department of Gastroenterology
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
0242-75-2100
irisawa@fmu.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Irisawa |
Fukushima Medical University Aizu Medical Center
Department of Gastroenterology
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492
0242-75-2100
irisawa@fmu.ac.jp
Department of Gastroenterology,
Fukushima Medical University Aizu Medical Center
Ministry of Health, Labor, and Welfare of Japan
OLYMPUS MEDICAL SYSTEMS CORP.(only device)
NO
2015 | Year | 02 | Month | 16 | Day |
Published
Completed
2015 | Year | 02 | Month | 16 | Day |
2015 | Year | 02 | Month | 16 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2015 | Year | 02 | Month | 16 | Day |
2018 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019199