CT-fluoroscopy-guided biopsy using a robot (Zerobot):single institution, single arm, open-label, prospective, feasibility trial - Robotic CT-guided biopsy

Hiraki Takao0 个研究点目标入组 10 人开始时间: 2018年8月31日最近更新: 2023年10月17日

试验速览

Insertion of the biopsy introducer needle with our robot was feasible and safe at several locations in humans.

•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

•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

发起方

Hiraki Takao