UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016445 |
|---|---|
| Receipt number | R000019094 |
| Scientific Title | Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy) |
| Date of disclosure of the study information | 2015/02/24 |
| Last modified on | 2015/09/08 14:06:33 |
* 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
Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy)
Acronym
The efficacy and safety of POEM
Scientific Title
Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy)
Scientific Title:Acronym
The efficacy and safety of POEM
Region
| Japan |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Per-oral endoscopic myotomy for esophageal achalasia (Per-oral endscopic myotomy: POEM) was certified advanced medical technology by the Ministry of Health, Labour and Welfare in July 2012 in Japan. This time, this treatment method is introduced into the Tohoku University Hospital, to examine the efficacy and safety of POEM for esophageal achalasia. After the end of this study, to perform the application of highly advanced medical treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)percentage-of-completion
2)all adverse event incidence
Key secondary outcomes
1) treatment time
2) postoperative hospital stay
3) subjective symptoms of the patient in the treatment before and after
4) health care costs during surgery hospitalization
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
POEM is performed
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) esophageal mortility function disorders patients and esophageal stenosis symptoms of esophageal achalasia
2) PS (ECOG Performance Status Scale): 0-2
3) Gender: both
4) major organs (bone marrow, heart, liver, kidney, lung function, etc.) is helathy, which can be general anesthesia
5)the consent in writing from the person
Key exclusion criteria
1) emergency surgery cases
2) medical doctor judged inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku university graduate school of medicine
Division name
Department of advanced surgery
Zip code
Address
1-1,seiryo-cyo,aoba-ku,sendai city,miyagi prefecture
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Sato |
Organization
Tohoku university
Division name
Department of Surgery, Division of Organ Transplantation, Reconstruction & Endoscopic Surgery
Zip code
Address
1-1,seiryou-cyo,aoba-ku,sendai city,miyagi prefecture
TEL
022-717-7214
Homepage URL
schiaki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku university hospital
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | 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
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2015 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
