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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000009279 |
Receipt No. | 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 |
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 | |
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Condition | |||
Condition | Healthy individual | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | CT colonography using automated carbon dioxide insufflation. | |
Interventions/Control_2 | CT colonography using manual carbon dioxide insufflation. | |
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Eligibility | ||||
Age-lower limit |
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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. |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Sakakibara Sapia Tower Clinic |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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. |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Main results already published | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010901 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |