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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000042008 |
Receipt No. | R000047944 |
Scientific Title | Assistant skill in ESD with a Clutch Cutter |
Date of disclosure of the study information | 2020/10/05 |
Last modified on | 2020/10/05 |
Basic information | ||
Public title | Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter | |
Acronym | Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter | |
Scientific Title | Assistant skill in ESD with a Clutch Cutter | |
Scientific Title:Acronym | Assistant skill in ESD with a Clutch Cutter | |
Region |
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Condition | ||
Condition | Gastric tumor | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine how assistant skill level affected the technical outcomes of gastric ESD-C using an ex vivo porcine training model. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Total procedure time |
Key secondary outcomes | En bloc resection rate, complete procedure rate, perforation rate, and each procedure time/speed for mucosal incision or submucosal dissection. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | All operators were gastrointestinal trainees with experience performing less than 20 ESD procedures. One assistant was defined as an expert who had experience in not only assisting but also operating in at least 50 ESD procedures. The remaining 2 assistants were defined as non-experts with experience in operating or assisting in no more than 10 ESD procedures. | |||
Key exclusion criteria | None | |||
Target sample size | 32 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Department of Medicine and Bioregulatory Science, Graduate School of Medicine | ||||||
Zip code | 812-8582 | ||||||
Address | 3-1-1, Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 0926425286 | ||||||
esaki_saiseikai@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu University | ||||||
Division name | Department of Medicine and Bioregulatory Science, Graduate School of Medicine | ||||||
Zip code | 812-8582 | ||||||
Address | 3- 1 - 1 Maidashi, Higashi-ku | ||||||
TEL | 0926425286 | ||||||
Homepage URL | |||||||
esaki_saiseikai@yahoo.co.jp |
Sponsor | |
Institute | Kitakyushu Municipal Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Kyushu University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kitakyushu Municipal Medical Center |
Address | 2-1-1 Bashaku Kokurakita-Ward Kitakyushu-City |
Tel | 093-541-1831 |
byou-iryou-chiken01@kitakyu-cho.jp. |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 32 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | This was a retrospective observational study. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047944 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |