UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016636 |
|---|---|
| Receipt number | R000019307 |
| Scientific Title | Evaluation of the effectiveness of colon capsule endoscopy for FIT(FOBT) positive patients with no symptoms who are unsuccessful or difficult to perform colonoscopy |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2015/02/25 18:11:08 |
* 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
Evaluation of the effectiveness of colon capsule endoscopy for FIT(FOBT) positive patients with no symptoms who are unsuccessful or difficult to perform colonoscopy
Acronym
Evaluation of the effectiveness of colon capsule endoscopy for FIT(FOBT) positive patients with no symptoms who are unsuccessful or difficult to perform colonoscopy
Scientific Title
Evaluation of the effectiveness of colon capsule endoscopy for FIT(FOBT) positive patients with no symptoms who are unsuccessful or difficult to perform colonoscopy
Scientific Title:Acronym
Evaluation of the effectiveness of colon capsule endoscopy for FIT(FOBT) positive patients with no symptoms who are unsuccessful or difficult to perform colonoscopy
Region
| Japan |
Condition
Condition
FIT (FOBT)+ patients with no symptoms who are unsuccessful or difficult to perform colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of colon capsule endoscopy for FIT (FOBT)+ patients with no symptoms who are unsuccessful or difficult to perform colonoscopy. Thiis is a pilot study in Japan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The findings of colon capsule endoscopy (mainly detecion of polyp lesion)
Key secondary outcomes
compleate examination rate, examination time, and cleansing state
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
colon capsule endoscopy
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
1)The patients with written informed cncent
2)FIT (FOBT)+ patients(mainly over 40 years old ) who are unsuccessful or difficult to perform colonoscopy
Key exclusion criteria
1)The patients with artifical cardiac pacemaker
2)The patients with / suspected intestinal stenosis
3)The patients with dysphasia
4)The patients with alarm signs
5)The patients with severe renal and/or liver dysfunctoin
6)The patients with allergy for laxative and/or pretreatment medicine
7)The patients with poor cleanliness of colon
8)The patients which judged inadequate by reoponsible doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Konosuke Nakaji |
Organization
Aishinkai Nakae Hospital
Division name
Endoscopy Center
Zip code
Address
30-1 Funadokoro Wakayama 640-8461
TEL
073-451-0222
parupurikopui@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Konosuke Nakaji |
Organization
Aishinkai Nakae Hospital
Division name
Endoscopy Center
Zip code
Address
30-1 Funadokoro Wakayama 640-8461
TEL
073-415-0222
Homepage URL
parupurikopui@yahoo.co.jp
Sponsor or person
Institute
Endoscopy Center, Aishinkai Nakae Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
医療法人愛晋会中江病院 内視鏡治療センター（和歌山県）、岐阜赤十字病院 内視鏡科（岐阜県）、石原消化器内科クリニック（香川県）、他
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 02 | 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 | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 02 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2015 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019307
