Unique ID issued by UMIN | UMIN000017796 |
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Receipt number | R000020617 |
Scientific Title | Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope |
Date of disclosure of the study information | 2015/06/03 |
Last modified on | 2018/10/12 09:28:33 |
Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Developing a scoring system to assess the endoscopic severity of ulcerative colitis using colon capsule endoscope
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
Aim1: To develope a scoring system to assess the endoscopic severity of ulcerative colitis (UC) using second generation colon capsule endoscope (CCE-2).
Aim2: To valideate the colon capsule scoring system for UC
Efficacy
Exploratory
Not applicable
Phase1: Correlation between developed colon capsule score for UC and value of fecal calprotectin.
Phase2: Kappa value for developed colon capsule score for UC.
Correlation between developed colon capsule score for UC and patinets outcome. Correlation between developed colon capsule score for UC and Lichtiger score, number of white blood cell, CRP level.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
Colon examination by using colon capsule endoscopy
18 | years-old | <= |
Not applicable |
Male and Female
Diagnosed UC patients
1) Ppatients with dysphagia.
2) Pregnant female.
3) Patient with pacemaker or other medical electronic equipment.
4) Patients who have history of the ileus or stricture or fistula of the intestine.
5) Patients who have history of radiation therapy.
6) Diagnosed or suspected Crohn's disease
100
1st name | |
Middle name | |
Last name | Haruhjiko Ogata, MD |
Keio University
Center for diagnostic therapeutic endoscopy
35 Shinanomachi, Shinjuku, Tokyo
+81-3-3353-1211
hogata@keio.jp
1st name | |
Middle name | |
Last name | Naoki Hosoe, MD |
Keio University
Center for diagnostic therapeutic endoscopy
35 Shinanomachi, Shinjuku, Tokyo
+81-3-3353-1211
hosenao@gmail.com
Keio University
Medtronic Co.
Profit organization
NO
慶應義塾大学 消化器内科
北里大学北里研究所病院 炎症性腸疾患先進治療センター
東京医科歯科大学 消化器内科
東邦大学医療センター佐倉病院 消化器内科
大船中央病院 消化器IBDセンター、光学診療部
2015 | Year | 06 | Month | 03 | Day |
Published
Completed
2015 | Year | 02 | Month | 16 | Day |
2015 | Year | 06 | Month | 03 | Day |
Phase1: The UC patients will be examined by CCE-2 and CS. And a scoring system to assess the endoscopic severity of ulcerative colitis (UC) using second generation colon capsule endoscope develope (CCE-2) is developed.
Phase2: The developed colon capsule score for UC will be validated.
2015 | Year | 06 | Month | 03 | Day |
2018 | Year | 10 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020617
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