UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012203 |
|---|---|
| Receipt number | R000014232 |
| Scientific Title | Chemically assisted endoscopic submucosal dissection(CA-ESD) with a rubber band tissue traction device |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2013/11/01 23:39:40 |
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Basic information
Public title
Chemically assisted endoscopic submucosal dissection(CA-ESD) with a rubber band tissue traction device
Acronym
CA-ESD with a traction device
Scientific Title
Chemically assisted endoscopic submucosal dissection(CA-ESD) with a rubber band tissue traction device
Scientific Title:Acronym
CA-ESD with a traction device
Region
| Japan |
Condition
Condition
esophageal tumors, gastric tumors, colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate technical feasibility of combination use of the chemically assisted technique (CA-ESD) and the rubber band device in the GI tract.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Procedural success
Key secondary outcomes
visibility of the dissection plane, bleeding, perforation, dissection time, en-bloc resection rate,
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
countertraction usings the rubber band traction device and using mesna as a submucosal injection solution.
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
| 25 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early GI tract lesions suitable for ESD
Key exclusion criteria
Patients who could not get informed consent. Patients with severe liver, heart, respiratory disease. History of hypersensitivity to mesna and latex. Women who were pregnant, lactating, or hoping to become pregnant during this study period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Ide |
Organization
The Jikei University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
dei0405@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ide |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscop
Zip code
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
dei0405@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 11 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Last modified on
| 2013 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014232
