CT-fluoroscopy-guided biopsy using a robot (Zerobot)

JRCT ID: jRCTs062180001

Registered date:31/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: lesions in an extremity or the trunk (e.g., a lung, renal, liver, or soft tissue mass)
• Date of first enrollment: 17/05/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Medical practice beyond usual medical care (biopsy using an unapproved medical device)

Outcome(s)

• Primary Outcome: Feasibility of robotic insertion of the biopsy introducer needle
• Secondary Outcome: Safety of robotic insertion of the biopsy introducer needle

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) requirement for a pathologic diagnosis of a lesion in an extremity or the trunk (e.g., a lung, renal, liver, or soft tissue mass) using CT-guided biopsy
2) A platelet count >=30,000/mm3
3) An international normalized ratio <1.5
4) Age 20 years or older
5) Ability to provide written informed consent
6) A lesion >=10 mm in largest diameter
7) A scheduled needle tract <11 cm in length

Exclude criteria

1) Limited mobility or impaired breath-holding ability
2) At-risk structures (e.g., the heart, great vessels, gastrointestinal tract, or pancreas) within 10 mm of the scheduled needle tract
3) Antiplatelet or anticoagulant therapy that cannot be withheld for the procedure
4) Inability to undergo anesthesia
5) A lesion located in the head and neck, central nervous system, spine, heart, great vessels, or gastrointestinal tract
6) A scheduled needle tract that passes through bone
7) Another biopsy for the lesion is scheduled
8) Invasive therapy, such as chemotherapy, radiation, and/or surgery, is scheduled to treat the lesion during the study period
9) Treatment for a psychiatric disorder
10) Pregnancy
11) Unsuitability for inclusion in the trial for whatever reason in the opinion of the investigators

Related Information

• Primary Sponsor: Hiraki Takao
• Source(s) of Monetary Support: CANON Medical Systems,Guerbet Japan,Siemens Healthcare,Daiichi-Sankyo,Toray Medical,Nihon Medi-Physics,FUJIFILM RI Pharma,FUJIFILM Medical,Fuji Pharma,Eisai,Nippon Kayaku
• Secondary ID(s): UMIN000030018