CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial
- Conditions
- cancer
- Registration Number
- JPRN-UMIN000030018
- Lead Sponsor
- Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Safety of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by adverse events and machine trouble of throbot