UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002363 |
|---|---|
| Receipt number | R000002899 |
| Scientific Title | Investigation of effectiveness of Third Eye Retrograde auxiliary imaging system (TER) in the colon |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2012/02/23 09:05:38 |
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Basic information
Public title
Investigation of effectiveness of Third Eye Retrograde auxiliary imaging system (TER) in the colon
Acronym
Third Eye Retrograde auxiliary imaging system (TER)
Scientific Title
Investigation of effectiveness of Third Eye Retrograde auxiliary imaging system (TER) in the colon
Scientific Title:Acronym
Third Eye Retrograde auxiliary imaging system (TER)
Region
| Japan |
Condition
Condition
Polyps in the ascending colon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison on detection rates of polyps and duration of procedure between conventional colonoscopy and one with TER
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rates of polyps in the ascending colon
Key secondary outcomes
Duration of the procedure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Colonoscopic observation without and with TER (The intervention period is during those two procedures in each case)
Interventions/Control_2
Colonoscopic observation with and without TER (The intervention period is during those two procedures in each case)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to have total colonoscopy for screening or surveillance
Key exclusion criteria
Patients who are under age or patients from whom cannot obtain the informed consent
Patients who cannot have bowel preparation
Patients who had undergone colon resections including the ileocecum and the ascending colon
Patients who have severe pre-existing diseases such as respiratory, circulatory or renal diseases, and etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Sunada |
Organization
Department of Medicine
Division of Gastroenterology
Endoscopy Center
Jichi Medical University
Division name
Department of Endoscopic Research and International Education (Funded by Fujifilm)
Zip code
Address
3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL
0285-58-7539
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keijiro Sunada |
Organization
Department of Medicine Division of Gastroenterology Endoscopy Center Jichi Medical University
Division name
Department of Endoscopic Research and International Education (Funded by Fujifilm)
Zip code
Address
3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
TEL
0285-58-7539
Homepage URL
k-sunada@jichi.ac.jp
Sponsor or person
Institute
Department of Medicine
Division of Gastroenterology
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Avantis medical systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
Name of secondary funder(s)
Mitsubishi Corporation
Fujifilm Corporation
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
| 2009 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | 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
| 2009 | Year | 08 | Month | 21 | Day |
Last modified on
| 2012 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002899
