UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008261 |
|---|---|
| Receipt number | R000009707 |
| Scientific Title | Evaluation of efficacy in endoscopic submucosal dissection to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer by new device "Nanoshooter". |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2022/07/04 09:27:18 |
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Basic information
Public title
Evaluation of efficacy in endoscopic submucosal dissection to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer by new device "Nanoshooter".
Acronym
Evaluation of efficacy in endoscopic submucosal dissection to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer by new device "Nanoshooter".
Scientific Title
Evaluation of efficacy in endoscopic submucosal dissection to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer by new device "Nanoshooter".
Scientific Title:Acronym
Evaluation of efficacy in endoscopic submucosal dissection to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer by new device "Nanoshooter".
Region
| Japan |
Condition
Condition
early gastric cancer (gastric adenoma)
early esophageal cancer
early pharyngeal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In comparison with underlying disease, old person, patient with the risk factor or ESD enforcement patient who does not hope for anesthesia, we evaluate efficacy and safety of nasal-ESD using new device "Nanoshooter" for early gastric cancer(gastric glands tumor), early esophageal cancer, and/or early pharyngeal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
1)Efficacy in nasal endoscopic submucosal dissection by oral way to early gastric cancer and/or early esophageal cancer.
2)Efficacy in nasal endoscopic submucosal dissection by nasal way to early gastric cancer, early esophageal cancer, and/or early pharyngeal cancer.
Safety
Treatment time, bleeding, a ratio of perforation, Visual Analog Scale
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Nanoshooter (Top)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria.
1)The patient's age is between 18 and 89 years old.
2)The patient who has diagnosis of early gastric cancer, gastric adenoma, early esophageal cancer, and/or early pharyngeal cancer.
3)Informed Consent.
4)Hospitalization.
5)The patient that contraception is possible during the study.
Key exclusion criteria
The exclusion criteria.
1)The patient who repeats hematemesis.
2)The patient who has a history of allergy to the use drug.
3)The patient that the withdrawal of coagulant and/or antiplatelet agent is impossible.
4)The patient with bad physical status.
5)The patient who cannot do to informed consent.
6)The patient who was considered ineligible by the investigators.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakatsu Nakamura |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakatsu Nakamura |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical 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
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
| 2012 | Year | 06 | Month | 26 | 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
| 2012 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009707
