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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033991 |
Receipt No. | R000038760 |
Scientific Title | Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy |
Date of disclosure of the study information | 2018/09/02 |
Last modified on | 2020/03/04 |
Basic information | ||
Public title | Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy | |
Acronym | Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy | |
Scientific Title | Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy | |
Scientific Title:Acronym | Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy | |
Region |
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Condition | ||
Condition | early gastric cancer, gastric adenoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic submucosal dissection for early gastric cancers and gastric adenomas. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1. diagnosed degree of perception of lesion
2. correct diagnosis rate of lesion range |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Endoscopic diagnosis and endoscopic therapy with 2D vision or 3D vision | |
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 | 1.Patients who have been diagnosed with early gastric cancers or gastric adenomas
2.Patients who understood study, and provided written consent based on their own will |
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Key exclusion criteria | 1.Patients in pregnancy or lactation
2.Patients who ever participated other clinical trials in latest 3 months 3.Patients decided to be contraindicated by the person in charge |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nippon Medical School | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-1-5, Sendagi, Bunkyo-ku, Tokyo | ||||||
TEL | 03-3822-2131 | ||||||
k-higuchi@nms.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nippon Medical School | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-1-5, Sendagi, Bunkyo-ku, Tokyo | ||||||
TEL | 03-3822-2131 | ||||||
Homepage URL | |||||||
k-higuchi@nms.ac.jp |
Sponsor | |
Institute | Nippon Medical School Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | |
Address | |
Tel | |
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 | |
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 | Completed | ||||||
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 |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000038760 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |