Unique ID issued by UMIN | UMIN000007107 |
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Receipt number | R000008338 |
Scientific Title | Phase I trial for feasibility of EGD with steady pressure automatically controlled endoscopy (SPACE). |
Date of disclosure of the study information | 2012/01/23 |
Last modified on | 2012/01/20 11:20:41 |
Phase I trial for feasibility of EGD with steady pressure automatically controlled endoscopy (SPACE).
Phase I trial for SPACE-EGD.
Phase I trial for feasibility of EGD with steady pressure automatically controlled endoscopy (SPACE).
Phase I trial for SPACE-EGD.
Japan |
Patients who undergo screening EGD.
Gastroenterology |
Others
NO
To evaluate feasibility and safety of screening EGD with steady pressure automatically controlled endoscopy (SPACE)
Safety
Completion rate of EGD
1) Rate of adverse event (based on NCI-CTCAE ver. 4.0)
2) The changes of vital signs during EGD
3) The findings of abdominal Xp immediately after EGD
4) Procedure time
5) Patients' Subjective score
6) Endoscopists' Subjective score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Screening EGD with steady pressure automatically controlled endoscopy (SPACE)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Patients who undergo screening EGD
2) Without past history of gastrectomy or esophagectomy.
3) The age is more than 20 and less than 80.
4) PS (ECOG) is 0 or 1.
5) Not to show significant abnormality by respiratory function test.
(FEV1.0 is more than 70%, %VC is more than 80%)
6) Written informed consent has been obtained.
1) Patients of Chronic Obstructive Pulmonary Disease (COPD)
2) In cases of suspected overt gastrointestinal bleeding or perforation.
3) To be judged inapropriate to participate this trial by contact person.
25
1st name | |
Middle name | |
Last name | Kiyokazu Nakajima |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
06-6876-0550
1st name | |
Middle name | |
Last name | Kiyokazu Nakajima |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
knakajima@surg1.med.osaka-u.ac.jp
Japan SPACE study group
none
Other
NO
大阪大学医学部付属病院
2012 | Year | 01 | Month | 23 | Day |
Unpublished
Preinitiation
2012 | Year | 01 | Month | 23 | Day |
2012 | Year | 01 | Month | 01 | Day |
2012 | Year | 01 | Month | 20 | Day |
2012 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008338
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