UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public 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 2019/06/21

* 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 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
Email 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
Email 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
Email 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
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
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
2019 Year 06 Month 21 Day


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


Contact us.