UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061627 |
|---|---|
| Receipt number | R000063780 |
| Scientific Title | Evaluation of disinfection on gastrointestinal endoscopes using functional water, electrolyzed acid water and ozonated water |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/20 07:29:00 |
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Basic information
Public title
Evaluation of disinfection on gastrointestinal endoscopes using functional water, electrolyzed acid water and ozonated water
Acronym
Evaluation of disinfection on GI endoscopes using functional water
Scientific Title
Evaluation of disinfection on gastrointestinal endoscopes using functional water, electrolyzed acid water and ozonated water
Scientific Title:Acronym
Evaluation of disinfection on GI endoscopes using functional water
Region
| Japan |
Condition
Condition
The flexible endoscopes for the gastrointestinal tract used for patients undergoing endoscopy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm that the effectiveness of the disinfection of the Clean Top KD-1 and the OED-1000S Plus ozone water-disinfector for flexible endoscopes for the digestive tract after clinical use is equivalent to that of the OER-6 water-disinfector.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-inferiority study of the effective rate of disinfection between two groups of the Clean Top KD-1 and the OED-1000S Plus ozone water-disinfector v.s. the OER-6
Key secondary outcomes
Number and species of bacteria
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This applies to flexible gastrointestinal endoscopes used for the observation, diagnosis, imaging, and treatment of internal lumens, body cavities, the oral cavity, and the trachea in patients visiting the hospital for endoscopic examinations.
Key exclusion criteria
1 Prion disease patients and flexible gastrointestinal endoscopes used on them.
2 Minor patients and flexible gastrointestinal endoscopes used on them.
3 Patients who refused to participate in the study and flexible gastrointestinal endoscopes used on them.
4 Cases where a water leak is detected during the pre-disinfection leak test of the endoscope.
5 Cases where the principal investigator or sub-investigator deems the implementation of the study inappropriate.
Target sample size
222
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kato |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
masakato89@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
Tokyo Jikei University School of Medicine Ethics Committee
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
crb@jikei.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | 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
222
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The primary manuscript of this study is currently under submission and undergoing peer review at a scientific journal. To comply with the journal's publication policy, the disclosure of results is delayed until the paper is accepted and published.
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
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study Design] This is a prospective cross-sectional observational study that will conduct bacterial culture tests before and after cleaning and disinfection of flexible endoscopes for the gastrointestinal tract used for observation, diagnosis, imaging, and treatment of internal lumens, body cavities, oral cavity, and trachea using test devices 1, 2, and a control device.
[Assignment and Selection Method] Based on the order of endoscopic examinations performed on the day, patients will be randomized into three groups (test device 1, test device 2, and control device) in a 1:1:1 ratio.
[Evaluation Method] Samples will be collected from the endoscopes before and after cleaning and disinfection (1.the entire portion inserted into the patient (insertion section), 2.the entire portion operated by the examiner (operation section), 3.inside the tubing) and bacterial tests will be performed to evaluate the disinfection effect.
[Target Number of Cases] 74 cases per group, for a total of 222 cases.
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063780
