UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027427 |
|---|---|
| Receipt number | 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 14:10:07 |
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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
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
radiol@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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