UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study comparison between two groups of intestinal tract cleansing agents for colon capsule endoscopy based on the colonoscopy as a golden standard, and usefulness of interpretation support by clinical engineering technologist.
Title of the study (Brief title)	A clinical study comparison between two groups of intestinal tract cleansing agents for colon capsule endoscopy based on the colonoscopy as a golden standard, and usefulness of interpretation support by clinical engineering technologist.
Region	Japan

Condition
Condition	suspect of colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the colon capsule endoscope, it is necessary to take an intestinal cleansing agent during the examination to promote the discharge of the capsule, the procedure is complicated that the amount of dosage is larger than the usual endoscope examination. In this study, we evaluate safety and efficiency of colon capsule endoscope with our hospital recruit volunteers after understanding that we do not have experience with this examination before using it with patient, in order to introduce the colon capsule endoscopy examination at our hospital newly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Comparison between two groups of intestinal tract washing method. Acceptability of whole examination including questionnaire degree of intestinal tract, intestinal tract washing method (questionnaire) 2. Utility of colon capsule endoscope with colonoscopy as a golden standard Colon capsule endoscope total colon observation rate, colon lesion detection rate 3. Usefulness of interpretation support by clinical engineering technologist. Lesion detection rate, interpretation time by doctor 4. Other Clinical information (gender, age, height, body weight, reason for colon examination, etc.)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	1) The method of intestinal tract cleansing; 2 days before the test, take 2 aperient tablets. The day before, take 190 ml of intestinal cleansing agent. The day of testing, take 1L of intestinal cleansing agent and 500 ml of water before swallowing the capsule. And also, on the day, until the release of the capsule is confirmed or until 15:30, every hour or every hour and half, intestinal tract cleansing drugs are orally administered or intravenous injections of intestinal peristalsis promotion drugs are carried out.
Interventions/Control_2	2) The method of intestinal tract cleansing; 2 days before the test, take 2 aperient tablets. The day before, take 1510 ml of intestinal cleansing agent. The day of testing, after swallowing the capsule, until the release of the capsule is confirmed, every hour or every two hours, intestinal tract cleansing drugs are orally administered or intravenous injections of intestinal peristalsis promotion drugs are carried out.
Interventions/Control_3	1) Image reading: First, the technician interprets the image, and then the doctor interprets and decides the diagnose it based on the information.
Interventions/Control_4	2) Image reading: The technician and the doctor interpret the image, respectively, and inquire about the result and decide the diagnosis.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Person among our staff who judged that need for colon examination with symptoms such as hematochezia and long term constipation and/ or diarrhea by the doctor. 2. Person who agreed to participate in this research with written informed consent, and obtained voluntary written agreement with sufficient understanding after receiving sufficient explanation in participating in this research. 3. Person who aged 20 years or older and under 70 years old when obtaining the consent.
Key exclusion criteria	1. Person who has dysphagia disorder. 2. Person who have a history of allergic to drugs used in this study. 3. A woman who is pregnant or suspected to be pregnant. 4. Person who will undergo MRI within 2 weeks after colon capsule endoscopy. 5. Person who have a history of abdominal surgery, and there is a possibility of adhesion. 6. Person with present or past history of small and large bowel obstruction. 7. Person who suspicious of having colorectal advanced carcinoma by tumor markers or symptoms. 8. Person inappropriate for this study by other reasons judged by investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Yukiko Baba
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name	Gastroenterology
Address	14-3 Nagata-cho, Kagoshima-city, Japan
TEL	099-226-9111
Email	crc-kenkyu@nanpuh.or.jp

Public contact
Name of contact person	Syuko Minami
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name	Clinical Research Support Office
Address	14-3 Nagata-cho, Kagoshima-city, Japan
TEL	099-805-2663
Homepage URL
Email	crc-kenkyu@nanpuh.or.jp

Sponsor
Institute	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Institute
Department

Funding Source
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 25 Day
Anticipated trial start date	2017 Year 06 Month 05 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 03 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032300