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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030018
Receipt No. R000033852
Scientific Title CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial
Date of disclosure of the study information 2017/11/17
Last modified on 2018/10/12

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Basic information
Public title CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial
Acronym CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion
Scientific Title CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial
Scientific Title:Acronym CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion
Region
Japan

Condition
Condition cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Surgery in general
Hepato-biliary-pancreatic surgery Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility of CT fluoroscopy-guided biopsy with Zerobot
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Feasibility of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by inserting a biopsy introducer needle into the lesion or near the lesion on CT images
Key secondary outcomes Safety of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by adverse events and machine trouble of throbot

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1 day, 1 time
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients who have a target lesion for which pathological diagnosis is required
2) patients with platelet count > 30,000/mm3
3) patients with PT-INR < 1.5
4) patients of 20-years-old or older
5) patients for whom informed consent is obtained
6) patients with a target lesion of at least 10-mm in diameter
7) patients with needle insertion length < 11 cm
Key exclusion criteria 1) patients who cannot limit body motion or hold their breath
2) patients whose needle tract for a target lesion is near (<10 mm) organs at risk such as the heart and aorta, gastrointestinal tract, pancreas, etc
3) patients who cannot stop antiplatelet or anticoagulant agents
4) patients who cannot undergo anesthesia
5) patients whose target lesion is in the head and neck, central nerve system, spinal cord, heart or aorta, and gastrointestinal tract
6) patients in whom the bone is an obstacle in needle tract
7) patients who undergo biopsy with other methods during study period
8) patients who undergo invasive therapy including chemotherapy, radiation, and surgery during study period
9) patients with mental disorder under treatment
10) pregnant patients
11) patients whom a physician judgesto be inappropriate
1
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tako Hiraki
Organization Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Radiology
Zip code
Address Kitaku, Shikatacho 2-5-1, Okayama
TEL 086-235-7313
Email takaoh@tc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tako Hiraki
Organization Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Radiology
Zip code
Address Kitaku, Shikatacho 2-5-1, Okayama
TEL 086-235-7313
Homepage URL
Email takaoh@tc4.so-net.ne.jp

Sponsor
Institute Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
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 11 Month 17 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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
2017 Year 11 Month 17 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033852

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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