UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033991 |
|---|---|
| Receipt number | 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 18:18:47 |
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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
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
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
| Other |
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
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
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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Higuchi |
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
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Higuchi |
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 or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
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
| 2018 | Year | 09 | Month | 02 | Day |
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
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038760
