Full Core Biopsy Needle vs Side Notch Biopsy Needle

Specimen Quality and Safety of Full-core vs. Side-notch Disposable Biopsy Needles in CT-guided Percutaneous Biopsy: a Single-center Randomized Controlled Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07800013

Enrollment

Registered

2026-09-02

Start date

2025-07-01

Completion date

2026-03-01

Last updated

2026-09-08

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

Conditions

Biopsy

Brief summary

Compare the quality of samples collected by the new fully automatic full-core biopsy needle with that of existing biopsy needles, including length, weight, and debris rate

Interventions

DEVICEMerit Medical CorVocet full-core disposable biopsy needle

Merit Medical CorVocet full-core disposable biopsy needle

DEVICEBard Side notch disposable biopsy needle

Bard Side notch disposable biopsy needle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

\- Age: 18-80 years old \- Imaging suggests deep organ space-occupying lesion, requiring biopsy to confirm its nature \- Coagulation function is basically normal (INR≤1.5) \- Lesion short diameter ≥4cm \- Signed informed consent form.

Exclusion criteria

\- Patients with coagulopathy who have not discontinued anticoagulant therapy \- Patients with severe infections or pregnancy \- Patients who, in the investigator's judgment, are not suitable for enrollment or have a high risk of puncture.

Design outcomes

Primary

Measure	Time frame	Description
Length of specimen	From enrollment to the end of biopsy at 1 week	Length of specimen after biopsy, mm
Mass	From enrollment to the end of biopsy at 1 week	Mass of specimen after biopsy, mg

Secondary

Measure	Time frame	Description
Fragmentation	From enrollment to the end of biopsy at 1 week	The grading of biopsy tissue fragmentation ranges from grade 1 to grade 5, with higher grades indicating more intact tissue
Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy	From enrollment to the end of biopsy at 1 week	Incidence of biopsy-related adverse events (AEs) occurring within 7 days post-procedure, including but not limited to bleeding, pneumothorax, infection, and pain. AEs will be graded according to CTCAE v5.0.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026