UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013710 |
|---|---|
| Receipt number | R000015988 |
| Scientific Title | safety and efficacy of the smart shooter in ESD procedure. |
| Date of disclosure of the study information | 2014/04/14 |
| Last modified on | 2015/10/16 19:38:02 |
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Basic information
Public title
safety and efficacy of the smart shooter in ESD procedure.
Acronym
T-HOPE 1401
Scientific Title
safety and efficacy of the smart shooter in ESD procedure.
Scientific Title:Acronym
T-HOPE 1401
Region
| Japan |
Condition
Condition
superficial gastrointestinal neoplasms
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficacy of the smart shooter in the ESD procedure for superficial gastrointestinal neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication rate in the ESD procedure using smart shooter
Key secondary outcomes
1. ESD procedure time
2. percentage of en-bloc resection
3. percentage of muscle damage
4. percentage of delayed bleeding
5. collapse of endoscopic view during ESD
6. duration from ESD to restart of food
7. duration of hospital stays from ESD
8. all adverse event during ESD procedure using SS
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
Use of Smart shooter in ESD procedure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients over 20 years old
2. patients with the lesion which should be treated by ESD procedure in gastrointestinal tract
3. patients treated using 260J or RD5 endoscope
4. patients with informed concents
Key exclusion criteria
1. patients judged inappropriate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Kaise |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon, minato-ku, tokyo, Japan
TEL
03-3588-1111
dkiku1230@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kikuchi |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon, minato-ku, tokyo, Japan
TEL
03-3588-1111
Homepage URL
dkiku1230@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2014 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 14 | Day |
Last modified on
| 2015 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015988
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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