UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000473 |
|---|---|
| Receipt number | R000000571 |
| Scientific Title | Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets |
| Date of disclosure of the study information | 2006/08/15 |
| Last modified on | 2011/02/22 13:03:46 |
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Basic information
Public title
Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets
Acronym
Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets
Scientific Title
Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets
Scientific Title:Acronym
Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets
Region
| Japan |
Condition
Condition
Artificial esophageal ulcerations after EMR
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the procedure of transplantation of autologous oral mucosal epithelial cell sheets and evaluate the effect of it on promoting wound healing and preventing stenosis on endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sakita-Miwa classification
The size of ulceration
Key secondary outcomes
Presence of pain
Period until beginning to eat
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
(1) The oral mucosal tissue is taken from the patient.
(2) The cultured autologous oral mucosal epithelial cell sheets are transplanted onto the artificial esophageal ulcerations after EMR.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will receive esophageal EMR
Key exclusion criteria
Oral cancers
Diabetes Mellitus
Steroid-administrated
Chemotherapy
Radiotherapy
Double cancers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ohki |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo Japan
TEL
03-3353-8111
Homepage URL
ohki@ige.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University
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
| 2006 | Year | 08 | Month | 15 | 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
| 2006 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 15 | Day |
Last modified on
| 2011 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000571
