UMIN-CTR Clinical Trial

Basic information
Public title	Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopy.
Acronym	Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopy.
Scientific Title	Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopy.
Scientific Title:Acronym	Safety and utility of the shielding devise for infection control during the lower gastrointestinal endoscopy.
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 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	Interventions 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 lower gastrointestinal endoscopy
Key exclusion criteria	Patients who did not agree to participate in this study
Target sample size	60

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
Email	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
Email	dkiku1230@gmail.com

Sponsor
Institute	Toranomon Hospital
Institute
Department

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
Email	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 21 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 28 Day
Date of IRB	2021 Year 07 Month 05 Day
Anticipated trial start date	2021 Year 08 Month 25 Day
Last follow-up date	2021 Year 12 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 21 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051689