Skip to main content
OpenTrials
Completed

NCT Number: NCT07800013

Full Core Biopsy Needle vs Side Notch Biopsy Needle

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biopsy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China hospital

Chengdu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Merit Medical CorVocet full-core disposable biopsy needle

Device

Merit Medical CorVocet full-core disposable biopsy needle

Bard Side notch disposable biopsy needle

Device

Bard Side notch disposable biopsy needle

Primary outcomes

  1. Length of specimen

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

    Length of specimen after biopsy, mm

  2. Mass

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

    Mass of specimen after biopsy, mg

Secondary outcomes

  1. Fragmentation

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.