UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003547 |
|---|---|
| Receipt number | R000004303 |
| Scientific Title | Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper) |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2010/04/27 03:14:00 |
* 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
Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper)
Acronym
New endoscopic device (Hood Clipper) for endoscopic submucosal dissection
Scientific Title
Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper)
Scientific Title:Acronym
New endoscopic device (Hood Clipper) for endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric,esopahgeal and rectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of new device to improve the efficacy and safety of endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint of this study is to evaluate the operation time of submucosal dissection using new device.
Key secondary outcomes
1) enbloc resection rate
2) safety
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
Endoscopic submucosal dissection
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Depth of invasion was limited to the mucosa or thin layer of submucosa (evaluated by endoscopy and /or endoscopic ultrasonography).
(2) N0M0 eavluated by CT scan (if submucosal invasion was suspected).
(3) Performance status(ECOG) is 0 or 1.
(4) fulfill all the criteria indicated below (within 30 days before treatment, ULN: upper limit of the institution).
i) white blood cell count
no fewer than 3000/mm3
no more than 10000/mm3
ii) hemoglobin
more than 9.0 g/dl(No blood transfusion was done within 14 days before treatment).
iii) platelet count
more than 100,000/mm3
iv) GOT
less or equal ULN X2.5
v) GPT
less or equal ULN X2.5
vi) T-Bil
less or equal 3.0mg/ml
vi) serum creatinine
less or equal 2.0mg/ml
(5) Written informed consent is essential.
Key exclusion criteria
(1) Cases with the component of poorly differetiated carcinoma in the biopsy specimen.
(2) Cases with active multiple cancers.
(3) Cases with severe complication.(i.e., decompensated liver cirrhosis, severe ischemic heart disease and renal failure, poorly-controlled diabetes mellitus, chronic respiratory failure requiring for continuous oxygen administration, Discontinuation of anticoagulant therapy can not be allowed).
(4) Woman in pregnancy (or woman of child bearing potential) and breast-feeding woman.
(5) Cases with uncontrolled psychiatric disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin'ichi Miyamoto |
Organization
Kyoto University
Division name
Department of Gatroenterology and Hepatology
Zip code
Address
54 Shogoin Kawaharachou Sakyo-ku, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Department of Gatroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
shmiyamo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit 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
| 2010 | Year | 05 | 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
Completed
Date of protocol fixation
| 2006 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | 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
| 2010 | Year | 04 | Month | 27 | Day |
Last modified on
| 2010 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004303
