UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045904 |
|---|---|
| Receipt number | R000051691 |
| Scientific Title | Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopic procedures. |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2021/10/28 19:43:53 |
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Basic information
Public title
Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopic procedures.
Acronym
Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopic procedures.
Scientific Title
Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopic procedures.
Scientific Title:Acronym
Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopic procedures.
Region
| Japan |
Condition
Condition
Lower gastrointestinal tract disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic procedures carry a risk of infection because there is a risk of exposure to the patient's intestinal juice and blood.
We are developing the new "Shielding Device for the Endoscopic Procedures".
The objective of this clinical study is to evaluate the safety and utility of the shielding devise.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discoloration area of water-sensitive recording paper due to the doctor's gloves after the endoscopy
Key secondary outcomes
Number of particles measured with a particle counter during endoscopy,
Discoloration area of water-sensitive paper due to the endoscopy technician's gloves after the endoscopy,
Oxygen saturation during the endoscopy,
Blood pressure during the endoscopy,
Use of sedatives,
VAS of pain of the endoscopy,
Endoscopy time,
Discoloration area of water-sensitive paper placed in behind of the patient
VAS of Operability in the endoscopy,
Adverse events caused by using the shielding devise,
Video of the diffusion of droplets in the endoscopy room,etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention Group: The band-like shield is attached to the buttocks of the patient during the endoscopy. In addition, the drape is attached to the endoscope, and the doctor operates the endoscope through the drape.
Interventions/Control_2
Control Group: The same equipment as normal endoscopy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients planning to undergo endoscopic mucosal resection (EMR), polypectomy, biopsy, during the lower gastrointestinal endoscopy.
Key exclusion criteria
Patients who did not agree to participate in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kikuchi |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
1058470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
dkiku1230@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kikuchi |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
1058470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
dkiku1230@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
OLYMPUS MEDICAL SYSTEMS CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital Research Ethics Committee
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2021 | Year | 10 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051691
