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Clinical Trials/NCT07800013
NCT07800013CompletedPhase 2

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

West China Hospital1 site in 1 country40 target enrollmentStarted: July 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Length of specimen
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Full Core

Experimental

Intervention: Merit Medical CorVocet full-core disposable biopsy needle (Device)

Side Notch

Active Comparator

Intervention: Bard Side notch disposable biopsy needle (Device)

Outcomes

Primary Outcomes

Length of specimen

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

Length of specimen after biopsy, mm

Mass

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

Mass of specimen after biopsy, mg

Secondary Outcomes

  • Fragmentation(From enrollment to the end of biopsy at 1 week)
  • Safty(From enrollment to the end of biopsy at 1 week)
  • Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy(From enrollment to the end of biopsy at 1 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hai Tao

Attending Physician

West China Hospital

Study Sites (1)

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