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Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes

NCT04500262 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2023-06-01

No results posted yet for this study

Summary

The aim of the study is to compare performance and safety of a newly developed 14-gauge open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically suspected breast cancer.

This is a Sponsor-initiated multicentre randomised trial. At the time of radiological breast cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in the axillary lymph nodes.

Conditions

Interventions

DEVICE

Open-tip pulsed needle biopsy (NeoNavia Biopsy System)

Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle

DEVICE

Core needle biopsy (CNB)

Ultrasound-guided biopsy using standard of care core needle biopsy

Sponsors & Collaborators

  • NeoDynamics AB

    lead INDUSTRY

Principal Investigators

  • Sarah Vinnicombe, Dr · Gloucestershire Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500262 on ClinicalTrials.gov