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CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial

CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion:single-center, single-arm, open-label, prospective, first-in-human, feasibility trial - CT fluoroscopy-guided biopsy using a robot (Zerobot) for needle insertion

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030018
Enrollment
10
Registered
2017-11-17
Start date
2018-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

1 day, 1 time

Sponsors

Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Safety of CT fluoroscopy-guided biopsy with Zerobot, which is evaluated by adverse events and machine trouble of throbot

Countries

Japan

Contacts

Public ContactTako Hiraki

Okayama University Graduate Shool of Medicine, Dentistry and Pharmaceutical Sciences Department of Radiology

takaoh@tc4.so-net.ne.jp086-235-7313

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026