UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035061 |
|---|---|
| Receipt number | R000039969 |
| Scientific Title | The efficiency of POET to treat esophageal submucosal tumor |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2020/11/06 19:20:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficiency of POET to treat esophageal submucosal tumor
Acronym
The efficiency of POET to treat esophageal submucosal tumor
Scientific Title
The efficiency of POET to treat esophageal submucosal tumor
Scientific Title:Acronym
The efficiency of POET to treat esophageal submucosal tumor
Region
| Japan |
Condition
Condition
esophageal submucosal tumor
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of POET to treat the submucosal tumor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of complications of POET
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
| Maneuver |
Interventions/Control_1
per oral endoscopic tumor resection
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
Esophageal submucosal tumor
Benign tumor confronting with preoperative biopsy results
2 to 4 cm in size
Those with symptoms such as dysphagia
Tumor growing tendency
Key exclusion criteria
Underage patient
Patients who can not obtain their consent
Patients taking anticoagulants, antiplatelet drugs, or other internal medications to promote bleeding
Other patients judged unsuitable by the attending physician
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama university hospital
Division name
Department of general medicine
Zip code
Address
Okayama city shikata 2-5-1
TEL
086-235-7219
y.sugi117@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama university hospital
Division name
Department of general medicine
Zip code
Address
Okayama city shikata 2-5-1
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama university hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
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 | 11 | Month | 28 | 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 | 11 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039969
