Full Core Biopsy Needle vs Side Notch Biopsy Needle

West China Hospital40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Biopsy

Interventions

Merit Medical CorVocet full-core disposable biopsy needleDEVICE

Merit Medical CorVocet full-core disposable biopsy needle

Bard Side notch disposable biopsy needleDEVICE

Bard Side notch disposable biopsy needle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

West China hospital

Chengdu, China

Outcomes

Primary Outcomes

Length of specimen

Length of specimen after biopsy, mm

Time frame: From enrollment to the end of biopsy at 1 week

Mass

Mass of specimen after biopsy, mg

Time frame: From enrollment to the end of biopsy at 1 week

Secondary Outcomes

Fragmentation

The grading of biopsy tissue fragmentation ranges from grade 1 to grade 5, with higher grades indicating more intact tissue

Time frame: From enrollment to the end of biopsy at 1 week

Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy

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.

Time frame: From enrollment to the end of biopsy at 1 week

Data from ClinicalTrials.gov

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