UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009279 |
|---|---|
| Receipt number | R000010901 |
| Scientific Title | Efficacy of automated carbon dioxide insufflation in CT colonography |
| Date of disclosure of the study information | 2012/11/07 |
| Last modified on | 2014/08/15 09:42:15 |
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Basic information
Public title
Efficacy of automated carbon dioxide insufflation in CT colonography
Acronym
Efficacy of automated carbon dioxide insufflation in CTC
Scientific Title
Efficacy of automated carbon dioxide insufflation in CT colonography
Scientific Title:Acronym
Efficacy of automated carbon dioxide insufflation in CTC
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of automated carbon dioxide insufflation in CT colonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of colon and small intestine distension per segment.
Key secondary outcomes
Data on perceived burden of CT colonography were collected using visual analogue scale (VAS) and a questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT colonography using automated carbon dioxide insufflation.
Interventions/Control_2
CT colonography using manual carbon dioxide insufflation.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy individual.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 40 years or older.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria
1) Patients with inflammatory bowel disease.
2) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
3) Contraindication for using Buscopan.
4) Previous colorectal surgery.
5) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
6) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
7) Possibility of pregnancy.
8) Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
9) Claustrophobia.
10) Severe deafness.
11) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata MD PhD |
Organization
Sakakibara Sapia Tower Clinic
Division name
Radiology Section
Zip code
Address
1-7-12 Sapiatower 7F, Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL
03-5288-0011
Nagata7@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata MD PhD |
Organization
Sakakibara Sapia Tower Clinic
Division name
Radiology Section
Zip code
Address
1-7-12 Sapiatower 7F, Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL
03-5288-0011
Homepage URL
Nagata7@aol.com
Sponsor or person
Institute
Sakakibara Sapia Tower Clinic
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
榊原サピアタワークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsgcs/51/4/51_465/_article/-char/ja/
Number of participants that the trial has enrolled
Results
Automated insufflation significantly improved distention overall compared to manual insufflation. No significant difference was seen in Visual Analogue Scale between manual insufflation and automated insufflation.
Automated carbon dioxide insufflation significantly improved colonic distention compared to manual insufflation. Participant acceptance was similar to that for manual insufflation.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010901
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
