UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027805 |
|---|---|
| Receipt number | 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 | 2021/08/24 19:45:43 |
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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
| Japan |
Condition
Condition
screening
Classification by specialty
| Gastroenterology |
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
| Device,equipment |
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.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
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
| 1st name | Sadaharu |
| Middle name | |
| Last name | Nouda |
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 or person
Institute
Osaka Medical College, Second Department of Internal Medicine
Institute
Department
Personal name
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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-1507-4540.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-1507-4540.pdf
Number of participants that the trial has enrolled
5
Results
To resolve the problems associated with the
existing self-propelling capsule endoscope, it may be necessary to not only improve the capsule endoscopes, but also to control the environment within the gastrointestinal
tract with medications and other means. Our results could guide other researchers in developing capsule endoscopes controllable from outside the body, thus allowing real-time
observation.
Results date posted
| 2021 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 23 | Day |
Baseline Characteristics
All five subjects were healthy men, with a median age of 36 years (range: 30 to 40 years).
Participant flow
The inclusion criteria were as follows: age between 20 and 65 years at the time of providing consent; provision of free informed consent on the basis of full understanding of the study protocol; and no history of medication use for 1 month before enrollment.
Adverse events
none
Outcome measures
The primary endpoint was the safety of the SPCE. The safety endpoints were determined as follows: vomiting or abdominal pain caused by intestinal obstruction due to CE, melena caused by mucosal damage due to the fin, and feeling ill secondary to the magnetic field.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031862
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