UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019632 |
|---|---|
| Receipt number | R000022689 |
| Scientific Title | Prospective study for the evaluation of whole gastrointestinal tract using patency capsule and colon capsule endoscopy |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2016/11/04 16:26:53 |
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Basic information
Public title
Prospective study for the evaluation of whole gastrointestinal tract
using patency capsule and colon capsule endoscopy
Acronym
Popcon study
Scientific Title
Prospective study for the evaluation of whole gastrointestinal tract
using patency capsule and colon capsule endoscopy
Scientific Title:Acronym
Popcon study
Region
| Japan |
Condition
Condition
suspected colon disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the evaluation of whole gastrointestinal tract and endoscopic observation using patency capsule and colon capsule endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the passage of whole gastrointestinal tract using colon capsule endoscopy when patency capsule is no trouble.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To use patency capsule at the evaluation of colon.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients aged 18 and more who adapt patency capsule and colon capsule endoscopy
Key exclusion criteria
contraindication to colon capsule endoscopy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanao Nakamura |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2172
makamura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Sato |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2172
Homepage URL
satoh11@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 04 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2016 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022689
