UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031862