UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040377
Receipt No. R000046079
Scientific Title Prospective evaluation of a newly developed 0.018-inch guidewire for endoscopic ultrasonography-guided interventions
Date of disclosure of the study information 2020/05/12
Last modified on 2020/05/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.