UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008504 |
|---|---|
| Receipt number | R000009637 |
| Scientific Title | Assessment of the safety and success rate of the mucosal cutting biopsy procedure |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/07/23 20:51:03 |
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Basic information
Public title
Assessment of the safety and success rate of the mucosal cutting biopsy procedure
Acronym
Assessment of the safety and success rate of the mucosal cutting biopsy procedure
Scientific Title
Assessment of the safety and success rate of the mucosal cutting biopsy procedure
Scientific Title:Acronym
Assessment of the safety and success rate of the mucosal cutting biopsy procedure
Region
| Japan |
Condition
Condition
gastrointestinal submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and success rate of the mucosal cutting biopsy procedure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of the mucosal cutting biopsy procedure
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
mucosal cutting biopsy 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
| Not applicable |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who require the biopsy for gastrointestinal submucosal tumors
Under 85 years
PS 0-2
Key exclusion criteria
Submucosal tumor in the gastrointestinal tract except for esophagus, stomach and colon
Patients with bleeding tendency
Patients with serious complications(heart disease, liver disease, renal disease ,etc.)
Submucosal tumor with extraluminal growth
Esophageal submucosal tumor with intramural growth
Submucosal tumor with ulcer
Patients who cannot undergo endoscopic submucosal dissection
Submucosal tumors in the location which is hard to performe regular endoscopic submucosal dissection
Patients without written informed consent
Patients considered ineligible for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosaku Moribata |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama city, Wakayama 641-0012, Japan
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosaku Moribata |
Organization
Second Department of Internal Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama city, Wakayama 641-0012, Japan
TEL
073-447-2300
Homepage URL
Sponsor or person
Institute
Second Department of Internal Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine, Wakayama 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 | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | 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
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2012 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009637
