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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029398
Receipt No. R000032300
Scientific 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.
Date of disclosure of the study information 2017/10/03
Last modified on 2018/10/02

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Basic information
Public 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.
Acronym 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.
Scientific 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yukiko Baba
Organization Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name Gastroenterology
Zip code
Address 14-3 Nagata-cho, Kagoshima-city, Japan
TEL 099-226-9111
Email crc-kenkyu@nanpuh.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Syuko Minami
Organization Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name Clinical Research Support Office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 05 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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