UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030018 |
|---|---|
| Receipt number | 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 12:04:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takaoh@tc4.so-net.ne.jp
Sponsor or person
Institute
Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033852
