UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006699 |
|---|---|
| Receipt number | R000007198 |
| Scientific Title | Prospective,cross-over,comparison between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists. |
| Date of disclosure of the study information | 2011/11/14 |
| Last modified on | 2011/11/10 21:11:20 |
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Basic information
Public title
Prospective,cross-over,comparison between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists.
Acronym
Prospective,cross-over,comparison between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists.
Scientific Title
Prospective,cross-over,comparison between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists.
Scientific Title:Acronym
Prospective,cross-over,comparison between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists.
Region
| Japan |
Condition
Condition
small intestine
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical usefulness and complication between spiral enteroscopy and double-balloon enteroscopy for inexperienced endoscopists
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1) duration of the examination
Key secondary outcomes
1) detection rate of lesions, success rate of endoscopic treatment, measurement of insertion depth, duration of X ray, procedure time
2) Rate of complication, amount of sedoanalgesia, VAS (Visual analogue scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
5 cases of double-balloon enteroscopy after spiral enteroscopy
Interventions/Control_2
5 cases of spiral enteroscopy after double-balloon enteroscopy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who will be performed small-bowel enteroscopy with suspected or known small bowel diseases
2) Over 20 years old, under 80 years old, at the point of agreement
3) Agreement of informed consent
Key exclusion criteria
1) Patients with perforation
2) Patients with blood coagulation abnormalities
3) Patients with anti-coagulant agents
4) Patients with severe hepatic disease
5) Patients with severe renal disease
6) Patients with severe pulmonary disease
7) Patients with severe circulatory disease
8) Pregnant and nursing women
9) Patients under poor condition or reject surgical operation for complication
10) Patients after operation of Billroth2
11) Patients with anaphylaxis against agents during examination
12) Inadequate patients for examination because of other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
Homepage URL
Sponsor or person
Institute
Department of Endoscopy, Hiroshima University Hospital
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
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
広島大学病院 Hiroshima University Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 14 | 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
| 2011 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 10 | Day |
Last modified on
| 2011 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007198
