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

Not Applicable

• Conditions: lesions in an extremity or the trunk (e.g., a lung, renal, liver, or soft tissue mass)

• Registration Number: JPRN-jRCTs062180001
• Lead Sponsor: Hiraki Takao

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-31
• Study Completion: 2018-10-04
• Results First Posted: 2019-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified