UMIN-CTR Clinical Trial

Basic information
Public title	Prospective evaluation of a newly developed 0.018-inch guidewire for endoscopic ultrasonography-guided interventions
Acronym	0.018-inch guidewire for EUS-guided intervention
Scientific Title	Prospective evaluation of a newly developed 0.018-inch guidewire for endoscopic ultrasonography-guided interventions
Scientific Title:Acronym	018-GW for EUS-guided intervention
Region	Japan

Condition
Condition	Biliary obstruction or abdominal abscess
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Interventional EUS (iEUS) has become common to access the biliary system and abdominal abscesses that should be drained. An ultrathin guidewire with a diameter of 0.018 inch Fielder 18 (TM) from Olympus Co. has become available, enabling application of 22-gauge puncture needle. The feasibility and safety of iEUS using the 0.018-inch guidewire should be evaluated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical feasibility of iEUS using the Fielder 18 guidewire (Fielder)
Key secondary outcomes	Procedure time, adverse events, clinical success

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	18 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients for whom iEUS using Fielder was considered to be necessary 2. Patients with written informed consent
Key exclusion criteria	1. Poor general condition defined by ASA classification class 4 or more 2. Previous registration in this study 3. Any factor for which the doctor considers inappropriate to perform the intervention or to register in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, Miyagino-ku
TEL	022-252-1111
Email	yoshi-hk@openhp.or.jp

Public contact
Name of contact person	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, Miyagino-ku
TEL	022-252-1111
Homepage URL
Email	yoshi-hk@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

Funding Source
Organization	None
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	IRB of Sendai City Medical Center
Address	5-22-1, Tsurugaya, Miyagino-ku
Tel	022-252-1111
Email	yoshihk44@yahoo.co.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	2020 Year 05 Month 12 Day

Related information
URL releasing protocol	Here
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	2020 Year 02 Month 03 Day
Date of IRB	2020 Year 05 Month 21 Day
Anticipated trial start date	2020 Year 02 Month 04 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 02 Month 28 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	Enrolled patients are observed for 1 week to evaluate adverse events.

Management information
Registered date	2020 Year 05 Month 12 Day
Last modified on	2020 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046079