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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023727
Receipt No. R000027331
Scientific Title Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Date of disclosure of the study information 2016/08/23
Last modified on 2016/12/26

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Basic information
Public title Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Acronym IV contrast infusion via 24-gauge side-holes catheter
Scientific Title Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Scientific Title:Acronym IV contrast infusion via 24-gauge side-holes catheter
Region
Japan

Condition
Condition All the patients who were referred for a suspect of pancreatic disease are eligible.
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To comparing the 24-gauge side-holes catheter and conventionally used 22-gauge end-hole catheters for the safety, the injection pressure, and the contrast enhancement on multi-detector computed tomography (MDCT).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The safety during intravenous contrast material administration.
Key secondary outcomes The injection pressure and the contrast enhancement.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Dynamic CT with the 24-gauge side-holes catheter.
Interventions/Control_2 Dynamic CT with the 22-gauge end-hole catheter.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients were randomized if they weighted more than 30 kg, if they were outpatients, and if aged 20 years old or older.
Key exclusion criteria Exclusion criteria were contraindications to iodinated contrast media, emergency cases, hemodialysis or renal failure patients, pregnant or lactating women, cases unable to place intravenous catheters, and cases with right median cubital vein puncture as an alternative route.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Tamura
Organization Iwate Medical University School of Medicine
Division name Department of Radiology
Zip code
Address 19-1 Uchimaru, Morioka, Japan
TEL 0196515111
Email a.akahane@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akio Tamura
Organization Iwate Medical University School of Medicine
Division name Department of Radiology
Zip code
Address 19-1 Uchimaru, Morioka, Japan
TEL 0196515111
Homepage URL
Email a.akahane@gmail.com

Sponsor
Institute Iwate Medical University School of Medicine
Institute
Department

Funding Source
Organization Iwate Medical University School of Medicine
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
Address
Tel
Email

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
2016 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0720048X16303862
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 Completed
Date of protocol fixation
2014 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 23 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027331

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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