UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040377 |
|---|---|
| Receipt number | 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 18:35:57 |
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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
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
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046079
