UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name

Organization

Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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