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Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes

NCT03975855 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2023-06-06

No results posted yet for this study

Summary

The aim of the study is to document performance characteristics of a biopsy device indicated for use in axillary lymph nodes, to provide basic insights into the complexity of axillary biopsy procedures and generate hypothesis for further larger comparative trials.

This is a Sponsor-initiated prospective, multicenter, registry trial. Patients that present with suspicious axillary lymph nodes at the time of breast cancer diagnosis undergo axillary sampling using the NeoNavia biopsy system. This is in accordance with clinical routine and current clinical guidelines. The system incorporates a new mechanism for controllable and precise needle insertion and a newly developed sampling needle for high yield sampling acquisition. It is approved for use in the breast and axillary lymph nodes.

Conditions

Interventions

DEVICE

NeoNavia® Biopsy System

Biopsy of axillary lymph node using the NeoNavia Biopsy System. The investigator shall obtain as many/large samples as judged adequate and sufficient for diagnosis.

Sponsors & Collaborators

  • NeoDynamics AB

    lead INDUSTRY

Principal Investigators

  • Marc Thill, PD Dr. · Leading Principal Investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-06-30
Completion
2023-04-11

Countries

  • Germany

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 NCT03975855 on ClinicalTrials.gov