UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029398 |
|---|---|
| Receipt number | 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 13:58:27 |
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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
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
crc-kenkyu@nanpuh.or.jp
Sponsor or person
Institute
Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032300
