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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027427
Receipt No. R000030615
Scientific Title Efficacy of an aspiration-type semiautomatic cutting biopsy needle in percutaneous image-guided biopsy: A prospective clinical study
Date of disclosure of the study information 2017/06/20
Last modified on 2018/11/20

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Basic information
Public title Efficacy of an aspiration-type semiautomatic cutting biopsy needle in percutaneous image-guided biopsy: A prospective clinical study
Acronym SCIRO-1702
Scientific Title Efficacy of an aspiration-type semiautomatic cutting biopsy needle in percutaneous image-guided biopsy: A prospective clinical study
Scientific Title:Acronym SCIRO-1702
Region
Japan

Condition
Condition Lung mass, Renal mass
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of an aspiration-type semiautomatic cutting biopsy needle for obtaining larger specimens by comparing the weight of the specimens obtained with and without aspiration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of the weight between the biopsy specimens obtained with and without aspiration.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 The first specimen is obtained with aspiration and the second without aspiration.
Interventions/Control_2 The first specimen is obtained without aspiration and the second with aspiration.
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 1. Patients indicated for percutaneous image-guided biopsy for histological diagnosis of lung or renal lesions.
2. The long axis diameter of the target lesion is more than 1.0 cm.
3. The patient is equal to or more than 20 years old.
4. Written informed consent for participation to this research is obtained from the patient.
Key exclusion criteria 1. The target lesion appears ground-glass opacity on high-resolution CT.
2. The target site of the lesion includes necrotic portion.
3. Inadequate coagulation or bone marrow function.
4. The patient is confirmed or suspected of being pregnant.
5. The patient has mental disorders including dementia.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Matsui
Organization Okayama University Medical School
Division name Department of Radiology
Zip code
Address 2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL 086-235-7313
Email y-matsui@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Matsui
Organization Okayama University Medical School
Division name Department of Radiology
Zip code
Address 2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL 086-235-7313
Homepage URL
Email radiol@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Japan Radiological Society
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 20 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 Completed
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 03 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
2017 Year 05 Month 21 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030615

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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