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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002363
Receipt No. 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

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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
Email

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
Email k-sunada@jichi.ac.jp

Sponsor
Institute Department of Medicine
Division of Gastroenterology
Jichi Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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