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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027805 |
Receipt No. | R000031862 |
Scientific Title | Examination of the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/12/21 |
Basic information | ||
Public title | Examination of the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract | |
Acronym | Examination of the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract | |
Scientific Title | Examination of the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract | |
Scientific Title:Acronym | Examination of the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract | |
Region |
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Condition | ||
Condition | screening | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the usefulness and safety of a self-propelling capsule endoscope for observing the digestive tract in healthy adults |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Emptying time for each section of the digestive tract (stomach, small intestine, large intestine) |
Key secondary outcomes | Detection of lesions, degree of intestinal lavage, and presence or absence of adverse events |
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 |
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Interventions/Control_1 | The digestive tract will be examined using a self-propelling capsule endoscope according to the following methods:
As pretreatment, 24 mg of sennoside will be orally administered at 21:00 the day before examination, and 2 L of intestinal lavage fluid at 7:00 on the day of examination. Each subject must swallow a self-propelling capsule endoscope at 10:00 on the day of examination. (1) Observation of the stomach: After the subject drinks 500 mL of water, the stomach will be examined while changing the posture. (2) Small intestine: It will be examined in a supine position. (3) Large intestine: After the self-propelling capsule endoscope reaches the cecum, 2 L of intestinal lavage fluid will be orally administered. After confirming dilation of the cecum, the large intestine will be examined in a supine position. |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Healthy adults, aged more than 20 years, from whom informed consent regarding participation in this study was obtained. | |||
Key exclusion criteria | Exclusion criteria for capsule endoscopy will be adopted
(1) Persons in whom nausea vomiting and abdominal distension suggest the presence of gastrointestinal occlusion or stenosis (2) Those with a history of gastrointestinal diseases, such as Crohn s disease (3) Those with a history of abdominal surgery (4) Those with a history of pelvic radiotherapy (5) Those wearing a cardiac pacemaker or other electric medical devices (6) Those with dysphagia (7) Those regularly taking NSAIDs |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Medical College | ||||||
Division name | Second Department of Internal Medicine | ||||||
Zip code | 5698686 | ||||||
Address | 2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan | ||||||
TEL | 072-683-1221 | ||||||
higuchi@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Medical College | ||||||
Division name | Second Department of Internal Medicine | ||||||
Zip code | 5698686 | ||||||
Address | 2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan | ||||||
TEL | 072-683-1221 | ||||||
Homepage URL | |||||||
sadaharu.nouda.1110@hotmail.co.jp |
Sponsor | |
Institute | Osaka Medical College, Second Department of Internal Medicine |
Institute | |
Department |
Funding Source | |
Organization | Osaka Medical College |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | MU Ltd.
Department of Mechanical and Systems Engineering Ryukoku University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Osaka Medical College |
Address | 2-7 Daigaku-machi, Takatsuki, Osaka, Japan |
Tel | 072-683-1221 |
rinri@osaka-med.ac.jp |
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 | 大阪医科大学附属病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000031862 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |