Unique ID issued by UMIN | UMIN000017074 |
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Receipt number | R000019769 |
Scientific Title | Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function. |
Date of disclosure of the study information | 2015/04/10 |
Last modified on | 2017/09/19 10:05:13 |
Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Japan |
Gastric or Esophageal Cancer
Gastroenterology |
Malignancy
NO
To evaluate the safety and efficacy of Hook knife with water jet function.
Safety,Efficacy
Exploratory
Phase II
The insertion number of injection needle per resected area.
Procedure duration of ESD per resected area (from injection to the end of dissection)
The number and amount of the injection from mucosa by injection needle per resected area
The number and amount of the injection to submucosal layer by injection needle per resected area
The number and amount of the injection from mucosa by Hook knife with water jet function per resected area
The number and amount of the injection to submucosal layer by Hook knife with water jet function per resected area
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Device,equipment |
Hook Knife
Hook Knife with Water Jet Function
20 | years-old | <= |
Not applicable |
Male and Female
1) Gastric or esophageal cancer which has indication of endoscopic submucosal dissection.
2) Written and signed consent for trial participation must be obtained from the patient.
1) Prior radiotherapy from mediastinum to upper abdomen.
2) The subject judged as without eligibility for the safety of this study by lead principal investigator or contact doctor.
40
1st name | |
Middle name | |
Last name | Tsuneo Oyama |
Saku Central Hospital Advanced Care Center
Department of Endoscopy
3400-28 Nakagomi, Saku, JAPAN
0267-62-8181
oyama@coral.ocn.ne.jp
1st name | |
Middle name | |
Last name | Akiko Takahashi |
Saku Central Hospital Advanced Care Center
Department of Endoscopy
3400-28 Nakagomi, Saku, JAPAN
0267-62-8181
ctroffice@sakuhp.or.jp
Saku Central Hospital Advanced Care Center
Saku Central Hospital Advanced Care Center
Self funding
NO
佐久総合病院佐久医療センター(長野県)
2015 | Year | 04 | Month | 10 | Day |
Published
Completed
2015 | Year | 03 | Month | 23 | Day |
2015 | Year | 04 | Month | 10 | Day |
2015 | Year | 11 | Month | 28 | Day |
2016 | Year | 09 | Month | 13 | Day |
2015 | Year | 04 | Month | 08 | Day |
2017 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019769
Research Plan | |
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